Double-blind randomized study of tramadol vs. paracetamol in analgesia after day-case tonsillectomy in children

Fifty children (2-9 years) scheduled for tonsillectomy were enrolled in a double-blind randomized prospective study to compare postoperative analgesia provided with propacetamol/paracetamol (acetaminophen) or tramadol. A standard anaesthetic technique was used; each patient received sufentanil 0.25 microg kg(-1) intravenously followed with either i.v. propacetamol 30 mg kg(-1) or tramadol 3 mg kg(-1) before surgical incision. For postoperative analgesia, each child received either tramadol drops (2.5 mg kg(-1)) or paracetamol (acetaminophen) suppositories (15 mg kg(-1)), 6 and 12 h after surgery the first day and three times a day during postoperative days 2 and 3. This dosage of paracetamol is lower than the current recommended dosage, which is 40 mg kg(-1) loading dose followed by 20 mg kg(-1) 8 h(-1). Rescue medication consisted of i.v. diclofenac (1 mg kg(-1)) during the first six postoperative hours and oral ibuprofen (6-9 mg kg(-1)) afterwards. Postoperative pain scores (Children's Hospital of Eastern Ontario Pain Scale) in recovery, numerical pain scale in the ward and at home, and rescue analgesic use were significantly lower in the tramadol group. No serious adverse effects were observed.     

Does 1 or 2 g paracetamol added to ketoprofen enhance analgesia in adult tonsillectomy patients?

Background: We have evaluated whether co-administration of intravenous (i.v.) paracetamol could enhance the analgesic efficacy of ketoprofen (a non-steroidal anti-inflammatory drug or NSAID) in patients undergoing a tonsillectomy.
Methods: This prospective, randomized, double-blinded and placebo-controlled add-on study with three parallel groups included 114 patients, aged 16–50 years, and scheduled for elective tonsillectomy. All patients were given ketoprofen 1 mg/kg i.v. after surgery, followed 5 min later by paracetamol 1 or 2 g i.v., or normal saline as a placebo. The primary outcome measure was the proportion of patients requiring oxycodone for rescue analgesia over the first 6 h (pain score >30/100 mm at rest or >50/100 mm during swallowing) after surgery.
Results: No difference was detected in the proportion of patients receiving oxycodone (31/37 in the paracetamol 1 g group, 29/39 in the paracetamol 2 g group and 30/38 in the ketoprofen-alone group) between the three groups. However, significantly less doses of rescue analgesia were provided in the paracetamol groups than in the ketoprofen-alone group ( P =0.005); among those who required rescue analgesia, 27% less oxycodone was required in the paracetamol 1 g group (80 doses, P =0.023) and 38% less in the paracetamol 2 g group (64 doses, P =0.002) than in the ketoprofen-alone group (106 doses).
Conclusion: Combining paracetamol i.v. with ketoprofen at the end of tonsillectomy did not reduce the proportion of the patients requiring rescue analgesia, but the number of opioid doses was less in the add-on groups.     

Comparison of the opioid-sparing efficacy of diclofenac and ketoprofen for 3 days after knee arthroplasty

BACKGROUND: Comparative postoperative non-steroidal anti-inflammatory drug (NSAID) studies in orthopedic patients have usually been restricted in time to the first postoperative day. The opioid-sparing effect of NSAIDs may be beneficial postoperatively as long as pain otherwise restricts ambulation and rehabilitation. We therefore compared the analgesic efficacy of the maximum recommended doses of diclofenac and ketoprofen for 3 days after knee arthroplasty. METHODS: We studied 64 knee arthroplasty patients, operated on under spinal anesthesia. In a randomized, double-blind and placebo-controlled fashion, the patients received either i.v. diclofenac 75 mg (n = 24), ketoprofen 100 mg (n = 24) or saline (n = 16) in the recovery room, followed by oral diclofenac 150 mg/day, ketoprofen 300 mg/day or placebo, respectively, for 3 days, supplemented by patient-controlled analgesia (PCA) with i.v. oxycodone. RESULTS: The mean consumption of oxycodone during the first, second and third study days was 45.3, 22.3 and 15.2 mg in the diclofenac group, 43.5, 37.5 and 21.8 mg in the ketoprofen group, and 61.2, 45.9 and 36.1 mg, respectively, in the placebo group. Oxycodone consumption was significantly lower (P < 0.05) in the ketoprofen group than in the placebo group in the postoperative period 13-24 h and 61-72 h. Diclofenac was superior to placebo in the postoperative period 25-48 h (P < 0.01), 49-60 h (P < 0.05) and to ketoprofen at 49-60 h (P < 0.05). During administration of diclofenac on days 1-3 and ketoprofen on day 2, the mean pain scores (VAS) were lower than in the placebo group (P < 0.05). Six patients had difficulties in operating the PCA device. There were no differences in blood loss. CONCLUSION: We conclude that in the first day after knee arthroplasty (13-24 h), ketoprofen exerted an opioid-sparing effect. After day 1 (25-60 h), with the doses used, diclofenac proved to be better than placebo, whereas ketoprofen was not.     

Comparison of caudal vs intravenous tramadol administered either preoperatively or postoperatively for pain relief in boys

BACKGROUND: In this study we compared caudal with intravenous (i.v.) tramadol given pre- or postoperatively for pain relief in boys having hypospadias repair. METHODS: The study was approved by the Ethics Committee and informed written consent was obtained from the parents of each patient. Patients (n = 134), aged 1-3 years, American Society of Anesthesiologists (ASA) physical status I, scheduled for hypospadias surgery were recruited. The patients were randomly allocated to one of the four groups: group I (n = 33), received 2 mg.kg(-1) (0.5 ml.kg(-1)) of caudal tramadol after the surgical procedure was completed, group II (n = 33) received 2 mg.kg(-1) (0.5 ml.kg(-1)) of caudal tramadol before incision, group III (n = 34) received 2 mg.kg(-1) tramadol intravenously, after surgery and group IV (n = 34) received 2 mg.kg(-1) tramadol intravenously, after anaesthesia induction. When the patients were fully awake in the recovery area, heart rate, arterial pressure, peripheral oxygen saturation, respiratory rate, pain and sedation scores were recorded at 5, 10, 15, 30, 60 min, and 2, 3, 4, 6, 12 and 24 h postoperatively and side-effects were noted. Pain was assessed using an objective pain score (OPS). RESULTS: The OPS were lower in caudal tramadol groups than in i.v. tramadol groups only at 3 h (P < 0.05). The duration of postoperative analgesia was longer in the caudal groups than in the i.v. groups (P = 0.001). However, the duration of postoperative analgesia was unaffected by the timing of administration. CONCLUSIONS: Caudal tramadol provides better and longer lasting postoperative analgesia than i.v. tramadol. These results also suggest that preoperative caudal tramadol did not provide any clinically perceptible benefits compared with postoperative caudal tramadol.     

Parenteral ketoprofen for pain management after adenoidectomy: comparison of intravenous and intramuscular routes of administration

BACKGROUND: Different parenteral routes of administration of NSAIDs such as ketoprofen have not been properly compared in children. This study was designed to compare the analgesic efficacy of intravenous and intramuscular ketoprofen for pain management in children after day-case adenoidectomy. METHODS: A total of 120 children, aged 1-9 years, who were scheduled to undergo adenoidectomy, were randomized to receive ketoprofen 2 mg/kg either intravenously with intramuscular placebo (n = 40) or ketoprofen 2 mg/kg intramuscularly with intravenous placebo (n = 40), or both intravenous and intramuscular placebo (n = 40) at induction of anesthesia. The study design was prospective and double-blind with parallel groups. Pain was assessed at rest and during swallowing using the Maunuksela pain scale during 3 h after surgery, and fentanyl i.v. was given for rescue analgesia. RESULTS: Children in the Placebo group needed significantly more doses of fentanyl (72 doses) than either children in the intravenous group (47 doses) or children in the intramuscular group (51 doses) (P = 0.021). In addition, a higher proportion of children in the Placebo group than in the two ketoprofen groups (P = 0.03) demanded rescue analgesic. No difference in the need for rescue analgesia or in pain scores was found between the two ketoprofen groups. Children in the intravenous group had less pain than children in the Placebo group. The difference was significant during swallowing at 1 h after surgery (P = 0.046) and for the worst pain observed during swallowing for 3 h after surgery (P = 0.022). There were no differences between the three groups with respect to operation times, amount of perioperative bleeding, or rate or extent of adverse events. CONCLUSION: The efficacy of intravenous and intramuscular ketoprofen was similar, and they both differed from placebo.     

Ketoprofen, diclofenac or ketorolac for pain after tonsillectomy in adults?

We have compared the analgesic and opioid sparing effect of three i.v. non-steroidal anti-inflammatory drugs with placebo in a randomized, double-blind, placebo-controlled study in 80 adult patients after elective tonsillectomy. A standard anaesthetic was used. After induction of anaesthesia, patients received ketoprofen 100 mg, diclofenac 75 mg or ketorolac 30 mg by i.v. infusion over 30 min. Patients in the placebo group received saline. Ketoprofen and diclofenac infusions were repeated after 12 h and ketorolac infusion at 6 h and 12 h. Oxycodone was used as rescue analgesic. Patients in the ketoprofen group requested 32% less opioid and patients in the diclofenac and ketorolac groups 42% less opioid than those in the placebo group (P < 0.05). There were one, two and six patients in the placebo, diclofenac and ketorolac groups, respectively, but none in the ketoprofen group, who did not request opioid analgesia during the study (P < 0.05, ketorolac vs placebo and ketoprofen). Visual analogue pain scores were similar in all groups. Visual analogue satisfaction scores were significantly higher in the diclofenac group compared with the placebo group. The incidence of nausea was 44-54%. There were no differences in the incidence of other adverse reactions. We conclude that all three non-steroidal anti-inflammatory drugs were superior to placebo after tonsillectomy.      

Comparison of pre- and postoperative administration of ketoprofen for analgesia after tonsillectomy in children

BACKGROUND: Tonsillectomy is commonly performed in children, but unfortunately it is associated with intense postoperative pain. The use and optimal timing of nonsteroidal anti-inflammatory drugs (e.g. ketoprofen) during tonsillectomy is controversial. METHODS: We evaluated the safety and efficacy of ketoprofen in 109 children, aged 3-16 years, during and after tonsillectomy in 1998-2000. Standardized anaesthesia was used. Forty-seven children received ketoprofen 0.5 mg.kg-1 at induction (preketoprofen group) and 42 children after surgery (postketoprofen group), followed by continuous ketoprofen infusion of 3 mg.kg-1 over 24 h in both groups; 20 children received normal saline (placebo group). Oxycodone was used for rescue analgesia. RESULTS: Pre- and postketoprofen groups did not differ in experienced pain or in opioid consumption in the first 24 h after surgery; demonstrating that ketoprofen did not have a pre-emptive effect. Patients in the placebo group received 30 more oxycodone doses than did patients in the ketoprofen groups, but the difference was not significant (P=0.074). Two patients (5) in the postketoprofen group had postoperative bleeding at 4 h and 26 h, respectively. Both patients required electrocautery to stop bleeding. Neither the incidence nor the severity of adverse events differed between study groups. CONCLUSIONS: This study demonstrates that ketoprofen did not have a preemptive effect and, at the dose used, did not perform statistically significantly better than placebo.     

Continuous epidural analgesia with bupivacaine-fentanyl versus patient-controlled analgesia with i.v. morphine for postoperative pain relief after knee ligament surgery

BACKGROUND: Both epidural analgesia and intravenous patient-controlled analgesia (PCA) have been found efficacious after various types of surgery. We compared the efficacy, safety, side effects and patient satisfaction of these methods in a randomized double-blind fashion after elective anterior cruciate ligament reconstruction of the knee. METHODS: Fifty-six patients had an epidural catheter placed at the L2-L3 interspace. Spinal anaesthesia with 15 mg of plain bupivacaine 5 mg/ml was performed at the L3-L4 interspace. After surgery the patients were randomly divided into three groups: 19 received a continuous epidural infusion with bupivacaine 1 mg/ml and fentanyl 10 mg/ml (F10), 19 patients received bupivacaine 1 mg/ml and fentanyl 5 microg/ml (F5) and 18 patients received saline (S). The rate of the epidural infusions was 0.1 ml kg(-1) h(-1). Each patient could also use an intravenous (i.v.) PCA device with 40 microg/kg bolus doses of morphine with a lockout period of 10 min and a maximum dose 240 microg kg(-1) h(-1). At the end of surgery ketoprofen 100 mg i.v. was given and continued orally three times a day. Patients were assessed for pain with a visual analogue scale (VAS) at rest and during activity, side effects and satisfaction at 3, 9 and 20 h. RESULTS: Both epidural infusions (F10, F5) provided better analgesia than epidural saline plus i.v. PCA (S) (P<0.05). There was slightly less nausea in the S group (NS). In spite of the difference in the quality of pain relief, there was no difference between the groups in patient satisfaction regarding analgesic therapy. CONCLUSION: Epidural infusion of fentanyl (1 microg kg(-1) h(-1) or 0.5 microg kg(-1) h(-1)) and bupivacaine (0.1 mg kg(-1) h(-1)) provided better pain relief but more side effects than intravenous morphine patient-controlled analgesia after knee ligament surgery. Almost all patients in all groups were satisfied with their pain relief.     

IV perioperative ketoprofen in small children during adenoidectomy

We have investigated the analgesic and opioid sparing effect of perioperative i.v. ketoprofen in a randomized, double-blind, placebo- controlled, parallel group study in 164 children, aged 1-7 yr, after adenoidectomy. A standard anaesthetic method was used and all children received fentanyl 1 microgram kg-1 i.v. during induction. Children in the ketoprofen group received ketoprofen 1 mg kg-1 i.v. after induction of anaesthesia followed by an infusion of ketoprofen 1 mg kg-1 over 2 h. Children in the placebo group received 0.9% saline. All children received fentanyl 1 microgram kg-1 i.v. as rescue analgesia. In the ketoprofen group less children required postoperative fentanyl (64% vs 77%, P = 0.006) and the total number of fentanyl doses was smaller compared with the placebo group (mean 1.0 (SD 1.1) (95% confidence intervals (CI) 0.8-1.3) vs 1.5 (1.1) (95% CI 1.2-1.7), P = 0.012). Worst pain observed in the postanaesthesia care unit was also lower in the ketoprofen group both at rest (P = 0.028) and during swallowing (P = 0.001). There were no difference in the number of adverse reactions between the groups. No serious adverse reactions occurred.      

Comparison of morphine and tramadol by patient-controlled analgesia for postoperative analgesia after tonsillectomy in children

BACKGROUND: Tramadol is an alternative to other opioids for postoperative pain management. This prospective, randomized, double-blind study was designed to compare the analgesic efficacy of patient-controlled tramadol with patient-controlled morphine for postoperative pain after tonsillectomy in children. METHOD: Sixty patients were allocated randomly to receive a patient-controlled analgesia (PCA) with either tramadol (T) or morphine (M), in a double-blind randomized study. When surgery was completed and hemostasis achieved, a standardized loading dose (0.1 mg.kg(-1) in group M, or 1 mg.kg(-1) in group T) was given. Thereafter, the children helped themselves to bolus doses (morphine (0.02 mg.kg(-1)) or tramadol (0.2 mg.kg(-1)) with lock-out times of 10 min without time limit via a PCA device. Scores for pain, sedation, nausea, and the bolus and total PCA doses, hemodynamic parameters and side effects were recorded at 5, 15, 30 min and 1, 2, 4, 6 and 24 h during PCA administration. RESULTS: Pain scores decreased significantly with time in both groups (P < 0.05), but were lower in group M than in group T at 1, 2 and 4 h (P < 0.05). Sedation scores increased with time in both groups (P < 0.05). However there were no significant differences in sedation scores between two groups at any study period, but nausea scores were higher in M group at 4, 6 and 24 h (P < 0.05). CONCLUSION: Intravenous patient-controlled tramadol is an alternative to patient-controlled morphine for postoperative pain relief in children after tonsillectomy. Morphine gave better postoperative pain relief, but was associated with a higher incidence of nausea than tramadol.     

Intraoperative loading attenuates nausea and vomiting of tramadol patient-controlled analgesia

PURPOSE: To evaluate the adverse effect profile of tramadol by patient-controlled analgesia (PCA) with administration of the loading dose either intraoperatively or postoperatively. METHODS: Sixty adult patients scheduled for elective abdominal surgery were enrolled into this prospective, randomized, double blind study. The patients were anesthetized in a similar manner. At the beginning of wound closure, the patients were randomly allocated to receive 5 mg x kg(-1) tramadol (Group 1) or normal saline (Group 2). In the post-anesthesia care unit (PACU), when patients in either group complained of pain, 30 mg x ml(-1) tramadol i.v. were given every three minutes until visual analogue scale (VAS) 3, followed by tramadol PCA with bolus dose of 30 mg and five minute lockout interval. Pain control and adverse effect assessments were done in the PACU and every six hours for 48 hr post drug by an independent observer. RESULTS: The loading dose was 290 +/- 45 mg in Group 1 and 315 +/- 148 mg in Group 2. In PACU, more nausea/vomiting both in terms of incidence (13/30, 43% vs 2/30, 6.6%, P < 0.05) and severity (nausea/vomiting score 2.5 +/- 2.0 vs 0.2 +/- 0.6, P < 0.05) was observed in patients with postoperative loading than in those with intraoperative loading of tramadol. CONCLUSION: Administering the loading dose of tramadol during surgery decreases the nausea/vomiting associated with high dose of tramadol and improves the quality of tramadol PCA in the relief of postoperative pain.     

Wound closure tramadol administration has a short-lived analgesic effect

PURPOSE: To evaluate the effects of tramadol administration at wound closure on postoperative pain and analgesic requirements in patients undergoing laparoscopic cholecystectomy. METHODS: In a prospective, randomized, double-blind study 80 patients were allocated into two groups (n = 40 in each) to receive either 200 mg tramadol or placebo i.v. at the time of wound closure. Postoperatively, all patients received tramadol from a patient-controlled analgesia (PCA) device. Pain, analgesic consumption, vital signs and side effects were recorded postoperatively for 24 hr. RESULTS: Administration of 200 mg tramadol at the time of wound closure was associated with a short-lived (60 min) reduction in pain scores and PCA consumption compared with placebo. Although the time to first request for analgesia after surgery was longer in patients who received tramadol at wound closure, there was no difference between the two groups with respect to pain scores or to the requirements of postoperative analgesia over the next 23 hr. The cumulative PCA consumption of tramadol in 24 hr was 139.4+/-108 and 102.4+/-106 mg in the placebo and tramadol groups, respectively (P = 0.06). CONCLUSIONS: Wound closure administration of 200 mg tramadol had a short-lived (60 min) analgesic effect but did not affect the long-term pain scores or analgesic requirements after laparoscopic cholecystectomy.     

Peroperative treatment with i.v. ketoprofen reduces pain and vomiting in children after strabismus surgery

Background: Strabismus surgery is associated with both pain and vomiting. Ketoprofen is widely used in adults to treat acute pain, but there are only few reports of its use in children. This randomised, double-blind, placebo-controlled, parallel group study was designed to investigate the analgesic effect of i.v. ketoprofen and its effect on the incidence of vomiting in children after day-case strabismus surgery.
Methods: Fifty-nine ASA 1 children, aged 1–12 years, entered the study. After premedication with diazepam and glycopyrronium, anaesthesia was induced with fentanyl and propofol and maintained with isoflurane. After induction the children in the ketoprofen group received 1 mg kg⁻¹ ketoprofen followed by an infusion of 1 mg kg⁻¹ ketoprofen over 2 h. In the placebo group, children received 0.9% saline. The postoperative pain was assessed by the Maunuksela pain score (0=no pain, 10=worst possible pain). All children received fentanyl as a rescue analgesic if the Maunuksela score was ≥3.
Results: In the ketoprofen group the number of fentanyl doses was smaller compared to the placebo group (median 1, quartiles (0–2) vs. 2 (1–3), P =0.047). The children in the ketoprofen group had less pain at 30 min ( P =0.02) and the worst pain observed in the post anaesthesia care unit was lower (3 (0–6) vs. 5 (3–8), P =0.035). The incidence of vomiting was less in the ketoprofen group compared to the placebo group (17% vs. 41%, P =0.036). No serious adverse reactions occurred.
Conclusion: We concluded that ketoprofen administered i.v. during the operation produced analgesia and reduced opioid consumption and the incidence of vomiting in children after strabismus surgery.     

The effect of intravenous ketoprofen on postoperative epidural sufentanil analgesia in children.

We compared the effect of IV ketoprofen and placebo as an adjuvant to epidural sufentanil analgesia after major surgery. We used a prospective, randomized, double-blinded, placebo-controlled, parallel-group study design in 54 children aged 1-15 yr who received a standardized anesthetic. Either IV ketoprofen or saline was administered in addition to an epidural sufentanil infusion, which was adjusted as required clinically. The study drug infusions were discontinued when pain scores were <3 on 0-10 scale for 6 h at a sufentanil infusion rate of 0.03 microg x kg(-1) x h(-1). Children in the ketoprofen group had a better analgesic effect, as shown by decreased need for sufentanil (mean [10th-90th percentiles] 8.3 [3.1-15.1] microg/kg vs 12.5 [6.2-18.9] microg/kg; P = 0.002) and earlier possibility to discontinuation of the epidural sufentanil (11 [46%] vs 3 [13%]; P = 0.014) before the end of the 72-h study period. In the ketoprofen group, median (range) pain scores were lower during activity at 24 h (2 [0-5] vs 5 [0-7]; P = 0.01) and at 72 h (0 [0-3] vs 2 [0-6]; P = 0.033), and fewer children had inadequate pain relief during activity at 24 h (0 vs 5; P = 0.037). Children who received ketoprofen required fewer infusion rate adjustments (12 [4-20] vs 17 [6-42]; P = 0.016). In the ketoprofen group, the incidence of desaturation (1 [4%] vs 6 [26%]; P = 0.035) and fever (3 [12%] vs 11 [48%]; P = 0.008) was less than that in the placebo group. We conclude that ketoprofen improved postoperative pain in children. IMPLICATIONS: We compared the effect of the IV nonsteroidal antiinflammatory drug ketoprofen versus placebo as adjuvants to epidural opioid analgesia with sufentanil. The continuous IV nonsteroidal antiinflammatory drug improved pain after major surgery in children receiving an epidural opioid. Although ketoprofen reduced epidural sufentanil requirements, the incidence of opioid-related adverse effects was not changed.     

Intravenous Ketoprofen in Postoperative Pain Treatment after Major Abdominal Surgery

In recent years considerable attention has been paid to the treatment of postoperative pain, with regard to the favorable effect of adequate analgesia on patient outcome. Multimodal analgesia (e.g., opioids and nonsteroidal anti-inflammatory drugs [NSAIDs] or local anesthetics) is recommended for effective postoperative pain relief. There are few data on the use of NSAIDs in postoperative pain treatment after abdominal surgery. We conducted a randomized, double-blind, placebo-controlled study to assess the analgesic efficacy and safety of ketoprofen after major abdominal surgery. One and nine hours postoperatively patients received 100 mg of ketoprofen i.v. (n = 21) or placebo (n = 22) in addition to a pain-treatment protocol consisting of continuous infusion of tramadol 200 mg and metamizol 5 g over 24 hours with additional 25 mg i.v. tramadol in case of inadequate analgesia. Pain was assessed by numeric rating scale at rest and at deep breath 3, 6, 12, and 24 hours postoperatively and the total dose of tramadol used in the first 24 hours was recorded. Patients in the ketoprofen group had significantly lower pain scores both at rest and at deep breath, at 3 (p < 0.01), 6, and 12 hours (p < 0.05) postoperatively. The 24-hour use of tramadol was significantly lower in the ketoprofen group (p < 0.01), with less nausea and vomiting. There were no bleeding complications or other adverse events related to ketoprofen therapy. The study showed the value of short-term use of ketoprofen to improve the quality of analgesia after major abdominal surgery without significant adverse effects.Presented in part at the 9th Symposium on Intensive Care Medicine, June 24–27, 2002, Brijuni Islands, Croatia, and at the Euroanaesthsia 2004 Meeting, June 5–8, 2004, Lisbon, Portugal     

Propacetamol and ketoprofen after thyroidectomy

BACKGROUND AND OBJECTIVE: The combination of non-opioid analgesic drugs, though widely used, has been rarely evaluated. The aim of this study was to compare the efficacy of propacetamol and the non-steroidal analgesic drug ketoprofen, alone or in combination, on pain relief after thyroid surgery performed using remifentanil. METHODS: Ninety-seven patients were randomly allocated to one of the three groups: propacetamol 2 g (32), ketoprofen 100 mg (33) and propacetamol 2 g + ketoprofen 100 mg (32). Each regimen was administered intravenously (i.v.) 30 min before the end of surgery and then every 6 h. If pain was not relieved, patients received an i.v. bolus of tramadol 100 mg. Tramadol consumption and pain intensity using a visual analogue scale was recorded at 1, 2, 8 and 14 h after the end of surgery. RESULTS: Pain scores were significantly higher with propacetamol compared with ketoprofen 2 h after surgery (35 +/- 3.7, 21 +/- 2.6, respectively; P < 0.01). The number of patients receiving tramadol was higher with propacetamol alone compared with the two other groups, 1 h (14/32, 4/33, 2/32, respectively; P > 0.01) and 2 h (24/32, 6/33, 8/32, respectively; P < 0.01) after surgery. There was no difference between ketoprofen alone and ketoprofen plus propacetamol, and there was no difference between the three groups from the 8th hour onward. CONCLUSIONS: In the immediate postoperative period after thyroid surgery performed using remifentanil, the concomitant use of propacetamol and ketoprofen does not improve analgesia compared with ketoprofen alone.     

Intravenous tramadol compared to propacetamol for postoperative analgesia following thyroidectomy

We compared the efficacy and side effects of propacetamol (P), an injectable prodrug of acetaminophen, 2 g and tramadol (T), a weak synthetic opioid, 1.5 mg.kg-1, given intravenously following thyroidectomy. 80 patients were randomly assigned to blindly receive one dose of P or T on request in the PACU. Residual pain was treated with i.v. PCA morphine. Pain and patient satisfaction were assessed with Visual Analog Scales. Demographic and peroperative data were comparable in both groups. Although the morphine consumption was comparable (p = 0.71), the decrease in VAS pain scores was significantly higher following tramadol (p = 0.03). More patients complained of nausea and vomiting (p = 0.01) during the first two hours following injection of tramadol, but there was no difference throughout the whole study. Oversedation was not observed in any group. We conclude that a single dose of tramadol provides a better quality of analgesia than propacetamol during the first six hours after thyroidectomy, but fails to ensure optimal analgesia, since VAS pain scores failed to fall below 3 despite the use of supplemental morphine.     

Efficacy of lornoxicam for acute postoperative pain relief after septoplasty: a comparison with diclofenac, ketoprofen, and dipyrone

STUDY OBJECTIVES: To compare the efficacy of injectable lornoxicam with diclofenac, ketoprofen, and dipyrone for acute postoperative pain. DESIGN: Prospective, randomized, placebo-controlled, double-blind study. SETTING: University hospital. PATIENTS: 200 ASA physical status I patients who were scheduled for elective septoplasty with general anesthesia. INTERVENTIONS: Patients were divided into 5 groups according to the intramuscularly administered analgesic drug: lornoxicam 8 mg (twice daily), diclofenac 75 mg (twice daily), ketoprofen 100 mg (twice daily), dipyrone 1 g (three times daily), and placebo (twice daily). MEASUREMENTS: Pain intensity was evaluated with a 0 to 100 mm Visual Analog Scale (VAS) at the 2nd, 4th, 6th, 8th, 12th, 16th, 20th, and 24th hour postoperatively. Intramuscular pethidine 1 mg/kg was administered to patients requiring additional analgesia, and treatment-related adverse effects were noted. MAIN RESULTS: Pethidine requirement was found to be significantly higher in the placebo group (1.8 mg/kg per 24 hours; 95% confidence interval, 1.5-2.2) than in the other groups (P = 0.001). No significant difference in opioid requirement was found among the treated groups (P > 0.05). Postoperative VAS scores were significantly lower at specific hours in the treatment groups when compared with placebo group (P < 0.05). No statistically significant difference in adverse effects was found among the groups studied (P > 0.05). CONCLUSIONS: Efficacy of lornoxicam in the management of acute postoperative pain was not superior to that of other nonopioid analgesics used in this study.     

Lack of pre-emptive analgesic effect of (R)-ketamine in laparoscopic cholecystectomy

AIM: This study evaluated the pre-emptive analgesic effect of intravenous (i.v.) (R)-ketamine in laparoscopic cholecystectomy. (R)-ketamine was used due to the lower incidence of side-effects. METHODS: Sixty patients who underwent surgery under general anesthesia were randomly allocated to 3 groups and studied in a double-blind manner. Two i.v. injections were administered: one after induction of anesthesia, approximately 3 min before surgery, and one after surgery. The placebo group (PLA, n = 20) received saline in both injections. The preoperative group (PRE, n = 20) received (R)-ketamine 1 mg/kg and then saline. The postoperative group (POST, n = 20) received saline and then (R)-ketamine 1 mg/kg. Postoperatively, the patients used a patient-controlled analgesia (PCA) pump. Pain was evaluated with a visual analog scale (VAS) at 30 min and every hour for 4 h and with a verbal rating scale (VRS) at 24 h and after 7 days. RESULTS: There were no occurrence of side-effects from (R)-ketamine. VAS and VRS at 1, 2, 3, and 4 h postoperatively showed no statistical differences. In the POST group, extubation was delayed and pain score (VAS) at 30 min postoperatively was significantly lower (P < 0.05) than the two other groups. There were no statistical differences in meperidine consumption during the first 4 h postoperatively and no differences in consumption of analgesics at 24 h and 7 days. CONCLUSION: In this study a 1 mg/kg dose of (R)-ketamine given at the end of surgery exerted a short-lasting hypnotic and analgesic effect. The same dose given preoperatively did not show postoperative analgesic effect or pre-emptive effect.     

Comparison of caudal ropivacaine, ropivacaine plus ketamine and ropivacaine plus tramadol administration for postoperative analgesia in children

BACKGROUND: The aim of this study was to compare the effect of single-dose caudal ropivacaine, ropivacaine plus ketamine and ropivacaine plus tramadol in children for postoperative pain management. METHODS: Following ethics committee approval and informed parental consent, 99 ASA PS I or II children, between 1 and 10 years of age, scheduled for elective inguinal hernia repair with general anaesthesia, were recruited. After induction of anaesthesia and placement of a laryngeal mask airway (LMATM), the patients were randomly divided into three groups to receive either caudal ropivacaine alone (0.4%, 2 mg x kg(-1)) in group R (n = 32) or ropivacaine (0.2%, 1 mg x kg(-1)) plus ketamine (0.25 mg x kg(-1)) in group RK (n = 33) or ropivacaine (0.2%, 1 mg x kg(-1)) plus tramadol (1 mg x kg(-1)) in group RT (n = 34) with a total volume of 0.5 ml x kg(-1). Systemic blood pressure (SBP and DBP), heart rate (HR), peripheral O2 saturation (SpO2), respiratory rate (RR), sedation and pain scores were recorded at 5, 10, 15 and 30 min, 1, 3, 4 and 6 h following recovery from anaesthesia. Pain was evaluated by Children's Hospital of Eastern Ontario Pain Scale, and sedation with a five-point sedation test. RESULTS: No difference was found regarding age, weight and duration of operation between the groups (P > 0.05). No patient experienced hypotension, bradycardia or respiratory depression. Duration of analgesia was longer in group RT (1377 +/- 204 min) than group R (1006 +/- 506 min) (P = 0.001). In the tramadol group, fewer patients required supplementary analgesics in the first 24 h (P = 0.005). Sedation scores were below 2 in all groups. Incidence of postoperative nausea and vomiting was higher in group RT (eight patients) and group RK (seven patients) than group R (one patient, P = 0.032). CONCLUSIONS: Ropivacaine (0.4%), ropivacaine (0.2%) plus ketamine (0.25 mg x kg(-1)) and ropivacaine (0.2%) plus tramadol (0.5 mg x kg(-1)) provided sufficient analgesia in children, but the duration of analgesia was longer in the RT group.