Additive analgesic effect of codeine and paracetamol can be detected in strong, but not moderate, pain after Caesarean section

Background : A randomized, double-blind, placebo-controlled single oral dose study was done in order to examine whether codeine has an additive analgesic effect to that of paracetamol for moderate and strong postoperative pain after abdominal surgery. The maximum recommended single dose of paracetamol 1000 mg (Paracet®) was compared with a combination of a submnximal dose of paracetamol 800 mg plus codeine 60 mg (Paralgin forte®) and placebo for pain relief after Caesarean section in 125 patients. Methods : Visual analogue pain intensity score (VAS 0–100 mm) and categorical pain relief score were recorded for 6 hours after the study drug intake. The main efficacy variables analyzed were: pain intensity difference and summed pain intensity differences during the first 3 and 6 h after study drug intake, total pain relief during the first 3 and 6 h, global evaluation score at the end of the observation period, and time to rescue analgesic. Results : Because of protocol violations, 17 patients were excluded from the analysis of effects. Among the 108 patients included in the analysis of analgesic effect, 49 patients had moderate baseline pain (VAS between 40 and 60 mm on a 100 mm scale), and 59 patients had strong baseline pain (VAS more than 60 mm). In patients with strong baseline pain, statistically highly significant differences were documented in efficacy variables between the active drugs and placebo and between the two active drugs. However, in patients with moderate baseline pain, no differences were found between the study drugs in any of the analgesic efficacy variables. Conclusion : This study thus confirms that codeine has additive analgesic effect to paracetamol in pain after surgery. Our results show the importance of initial pain intensity in postoperative assessment of analgesic drugs. Assay-sensitivity and test power are increased by selecting patients with sufficiently high initial pain intensity and by comparing groups of patients with identical surgery and similar demographic variables.     

Single-dose intravenous paracetamol or propacetamol for prevention or treatment of postoperative pain: a systematic review and meta-analysis

Paracetamol is the most commonly prescribed analgesic for the treatment of acute pain. The efficacy and safety of i.v. formulations of paracetamol is unclear. We performed a systematic search (multiple databases, bibliographies, any language, to May 2010) for single-dose, randomized, controlled clinical trials of propacetamol or i.v. paracetamol for acute postoperative pain in adults or children. Thirty-six studies involving 3896 patients were included. For the primary outcome, 37% of patients (240/367) receiving propacetamol or i.v. paracetamol experienced at least 50% pain relief over 4 h compared with 16% (68/527) receiving placebo (number needed to treat=4.0; 95% confidence interval, 3.5-4.8). The proportion of patients in propacetamol or i.v. paracetamol groups experiencing at least 50% pain relief diminished over 6 h. Patients receiving propacetamol or paracetamol required 30% less opioid over 4 h and 16% less opioid over 6 h than those receiving placebo. However, this did not translate to a reduction in opioid-induced adverse events (AEs). Similar comparisons between propacetamol or i.v. paracetamol and active comparators were either not statistically significant, not clinically significant, or both. AEs occurred at similar rates with propacetamol or i.v. paracetamol and placebo. However, pain on infusion occurred more frequently in those receiving propacetamol compared with placebo (23% vs 1%). A single dose of either propacetamol or i.v. paracetamol provides around 4 h of effective analgesia for about 37% of patients with acute postoperative pain. Both formulations are associated with few AEs, although patients receiving propacetamol have a higher incidence of pain on infusion.     

Analgesic effect of ibuprofen in pain after episiotomy]

The relief of post-episiotomy pain was investigated in three groups of women, ranked ASA 1 or 2, using either a single dose of 400 mg of ibuprofen (n = 31), or 1 g of paracetamol (n = 28) or placebo (n = 31). Pain intensity was assessed with a visual analogic scale, a verbal scale and pain relief scores after half an hour, 1, 2, 3, 4, 5 and 6 h. The day after treatment, patients rated the quality of pain relief, and were asked whether they wished to take again the same drug for the same type of pain. In the placebo and paracetamol groups, respectively 22 and 16 patients asked for usual treatment before the sixth hour, whereas only 5 did so in the ibuprofen group (p less than 0.001). Ibuprofen was more effective after one hour than either of the other two drugs, whatever the scale or parameter used. In the ibuprofen group, the lower pain score was observed at the third hour. At six hours, the pain score did not differ from that three hours earlier. On the day after treatment, 22 patients from the ibuprofen group considered pain relief to have been good or excellent, versus 8 and 5 in the paracetamol and placebo groups respectively (p less than 0.001). Similarly, 24 patients from the ibuprofen group would accept the same drug again for the same type of pain, as opposed to 8 and 5 from the paracetamol and placebo groups respectively (p less than 0.01). The only side-effect reported was abdominal pain in one patient (placebo group).(ABSTRACT TRUNCATED AT 250 WORDS)     

Intravenous acetaminophen (paracetamol): comparable analgesic efficacy, but better local safety than its prodrug, propacetamol, for postoperative pain after third molar surgery

We compared an acetaminophen (paracetamol) 1 g (n = 51) formulation for infusion with propacetamol 2 g (n = 51) and placebo (n = 50) in a randomized, controlled, double-blind, parallel group trial in patients with moderate-to-severe pain after third molar surgery. Treatment efficacy was assessed in house for 6 h after starting the 15-min infusion. Significant effects versus placebo (P < 0.01) were obtained with both active treatments on pain relief, pain intensity difference on a 100-mm visual analog scale, and on a categorical scale (except for propacetamol at 6 h). No significant differences were noted between active groups except at 1 h. Six-hour weighted sums of primary assessments showed significantly better efficacy than placebo (P < 0.0001) and no difference between active treatments. Median stopwatch time to onset of pain relief for active treatment was 6-8 min after infusion start. Active treatments showed comparable efficacy with a significantly longer duration of analgesia and better patients' global evaluation compared with placebo. The incidence of patients reporting local pain at the infusion site was significantly less frequent after IV acetaminophen or placebo (0%) in comparison with propacetamol (49%). In conclusion, acetaminophen 1 g and propacetamol 2 g were superior to placebo regarding analgesic efficacy, with a more frequent incidence of local pain at the infusion site for propacetamol.     

Tolerance and analgesic efficacy of a new i.v. paracetamol solution in children after inguinal hernia repair

BACKGROUND: A new intravenous (i.v.) formulation of paracetamol and propacetamol (prodrug of paracetamol) were compared to determine tolerance and relative analgesic efficacy during the first 6 h after inguinal hernia repair performed under general anesthesia combined with ilioinguinal block in children. METHODS: A total of 183 ASA I or II in-patients, aged 1-12 years, admitted for unilateral inguinal hernia repair were randomized to receive in a double-blind design either i.v. paracetamol 15 mg.kg(-1) (n = 95) or propacetamol 30 mg.kg(-1) (n = 88) for postoperative pain relief as soon as pain intensity was greater than 30 on a 100 mm visual analog scale. All patients were evaluated for efficacy and tolerance. Efficacy was evaluated between 15 min and 6 h after the start of the 15 min infusion. RESULTS: The most frequently reported adverse event was injection site pain, which was significantly reduced in the new formulation group (i.v. paracetamol 14.7% vs propacetamol 33.0% of children, P = 0.005). No significant difference was obtained between treatments on pain relief (PR), pain intensity difference (PAID) from baseline, and objective pain scale intensity difference (OPSD). Also, treatment effects did not differ significantly for maximum values and weighted sums of PR, PAID (investigator and child rated), OPSD, time to first request for rescue medication, proportion of children requesting rescue medication, and investigators' global treatment satisfaction. CONCLUSION: A single infusion of i.v. paracetamol 15 mg.kg(-1) produced analgesia similar to a single infusion of propacetamol 30 mg.kg(-1) following inguinal hernia repair in children. Paracetamol i.v. 15 mg.kg(-1) was better tolerated at the injection site than propacetamol.     

Application of sublingual buprenorphine in combination with naproxen or paracetamol for post-operative pain relief in cholecystectomy patients in a double-blind study

In a double-blind, placebo-controlled study in 125 patients undergoing a cholecystectomy, a comparison was made of the quality of post-operative pain relief during 'patient-controlled' intake of sublingual buprenorphine in combination with either rectally administered naproxen 1000 mg/24 h, paracetamol 4000 mg/24 h or a placebo. Results obtained in 97 patients were analysed. Five of these patients needed a rescue medication with morphine hydrochloride intramuscularly because of insufficient pain relief or because of nausea and vomiting. The quality of pain relief, as measured on a four-point scale, was comparable in all three groups throughout the study period and no significant differences became apparent. Only on the day of surgery (day 0) was intake of buprenorphine significantly greater in the placebo group (2.3 tablets/24 h) than in the naproxen and paracetamol groups (1.8 and 1.5 tablets/24 h, respectively). It is concluded that after cholecystectomy 'patient-controlled' intake of sublingual buprenorphine as a sole agent provides acceptable pain relief in about 80% of patients. More elaborate methods, such as intravenous patient-controlled analgesia, might be necessary to achieve good pain relief in the remainder of these patients.     

Analgesic efficacy of diclofenac in combination with morphine and paracetamol after mastectomy and immediate breast reconstruction

BACKGROUND: Breast cancer treatment with mastectomy and immediate breast reconstruction (IBR) is associated with intense pain in the primary post-operative period. The present prospective, placebo-controlled and double-blind study aimed to evaluate the analgesic efficacy of diclofenac, a non-steroid anti-inflammatory drug (NSAID), in combination with paracetamol and opioids. This was done by 64-h assessment of post-operative pain intensity, opioid consumption, blood loss, nausea and tiredness. METHODS: Fifty women selected for mastectomy and IBR with submuscular implants with or without axillary lymph node dissection (ALND) were randomized to receive diclofenac 50 mg x 3 or placebo rectally in addition to oral paracetamol and intravenous opioids delivered using a patient-controlled analgesia (PCA) technique. RESULTS: During the first 20 h post-surgery, patients who received diclofenac experienced significantly less pain when resting than those who received placebo. When moving, a non-significant estimated difference in pain in favour of diclofenac was also noted. Opioid consumption during the first 6 h post-operatively was 34% less with diclofenac than with placebo. Means (SD) were 16.9 (10.3) mg and 25.6 (10.2) mg, respectively (P = 0.007). After 64 h, the difference was no longer statistically significant. Post-operative bleeding was significantly higher with diclofenac than with placebo (P < 0.01). Nausea and tiredness did not differ between the groups. CONCLUSIONS: The addition of NSAID to paracetamol and opioid-PCA reduced opioid consumption and improved pain relief during the first 20 h at rest but was not convincingly effective during mobilization. Post-operative blood loss was higher with diclofenac.     

The efficacy and safety of oral immediate-release oxymorphone for postsurgical pain

In this double-blind, parallel-group study, we compared 3 oxymorphone immediate-release (IR) doses with placebo for efficacy and with oxycodone IR and placebo for safety in patients with acute moderate-to-severe postsurgical pain. During the single-dose phase (n = 300), patients received oxymorphone IR 10, 20, or 30 mg; oxycodone IR 10 mg; or placebo. All oxymorphone IR doses were superior for providing pain relief for 8 h (P < 0.05), with a significant analgesic dose response (P < 0.001). Significant pain intensity differences occurred by 45 min (20- and 30-mg doses; P < 0.05). Discontinuations for lack of efficacy totaled 42% among placebo-treated patients and 27% among those treated with oxymorphone IR. Patients requiring rescue medication after 3 h were allowed to receive additional study drug every 4 to 6 h as needed for the multiple-dose phase (n = 164). All oxymorphone groups maintained analgesia for 48 h. The median dosing interval was >9.5 h for oxymorphone IR 30 mg and > or =7 h for the other groups. Opioid-related adverse events, similar among groups, were generally mild or moderate. Oxymorphone IR 10, 20, or 30 mg provided significant dose-related pain relief compared with placebo, and this relief was maintained over several days with a safety profile comparable to that of oxycodone IR.     

Methylprednisolone intravenously 1 day after surgery has sustained analgesic and opioid-sparing effects

BACKGROUND: In previous studies on glucocorticoids for postoperative pain, the test drug has been given perioperatively, usually before measurement of baseline pain. In order to evaluate the time course and magnitude of the analgesic effect of a glucocorticoid in well-established postoperative pain, we compared methylprednisolone with ketorolac and placebo, after assessment of baseline pain on the first postoperative day. METHODS: This was a double-blind, single dose, randomized, parallel comparison of intravenous (i.v.) methylprednisolone 125 mg, ketorolac 30 mg as an active control, and placebo in 75 patients with moderate to severe pain 1 day after orthopaedic surgery. Outcome variables were pain intensity (0-100 VAS), pain relief (0-4 PAR) and rescue opioid consumption. RESULTS: Methylprednisolone was not significantly different from ketorolac and gave significantly lower pain intensity from 1 h (0-6 h, P < 0.02), and more pain relief 2-6 h after test drugs (P < 0.05) compared with placebo. After 24 h, pain intensity was lower in both active drug groups compared with placebo (methylprednisolone, P < 0.0001; ketorolac, P < 0.007). Number needed to treat (NNT) calculated from patients having more than at least 50% of maximum obtainable total pain relief during the first 6 h (>50%maxTOTPAR(6 h)) was 3.6 for methylprednisolone and 3.1 for ketorolac. Number needed to treat calculated from the percentage reporting at least 50% pain relief for at least 4 h (>50%PAR(4 h)) was 2.8 for both groups. Opioid consumption was significantly reduced for 72 h after methylprednisolone compared with ketorolac (P < 0.02) and placebo (P < 0.003). CONCLUSION: Methylprednisolone 125 mg i.v. 1 day after surgery gave similar early reduction of pain as i.v. ketorolac 30 mg. Less pain than placebo 24 h after methylprednisolone, and lower opioid consumption for 72 h compared with ketorolac and placebo indicate sustained analgesic effects of methylprednisolone.     

The relative potency of oral transmucosal fentanyl citrate compared with intravenous morphine in the treatment of moderate to severe postoperative pain.

Pharmacokinetic studies have shown that oral transmucosal absorption of fentanyl is relatively rapid compared with gastrointestinal absorption, and it results in increased bioavailability. We designed this study to establish the relative potency of oral transmucosal fentanyl citrate (OTFC) compared with i.v. morphine in 133 postoperative patients. The morning after surgery, patients randomly received one dose of either OTFC (200 or 800 microg) and a placebo i.v. injection or i.v. morphine (2 or 10 mg) and an oral transmucosal placebo unit. Pain intensity, pain relief, time to meaningful pain relief, and time to remedication were recorded. Median time to onset of relief was approximately 5 min for all groups. Over the first hour, little difference among treatment groups was seen for pain intensity and pain relief. By 2 h after study drug administration, 800 microg of OTFC and 10 mg of i.v. morphine generally produced similar analgesia, which was better than the smaller doses. Duration of analgesia with the larger doses (800 microg of OTFC and 10 mg of morphine) was similar and longer that produced by the smaller doses. The larger doses of OTFC and morphine produced better and more sustained analgesia than 200 microg of OTFC or 2 mg of morphine. IMPLICATIONS: The relative potency of oral transmucosal fentanyl citrate (OTFC) to i.v. morphine was 8-14:1. In this postoperative setting, OTFC produced rapid pain relief similar to that produced by i.v. morphine. The larger doses of OTFC (800 microg) and morphine (10 mg) produced better and more sustained analgesia than 200 microg of OTFC or 2 mg of morphine.     

Analgesic efficacy of parenteral paracetamol (propacetamol) and diclofenac in post-operative orthopaedic pain

BACKGROUND: Propacetamol is an injectable pro-drug of paracetamol (acetaminophen) with analgesic and antipyretic activities, especially used in the post-operative period. The aim of this study was to assess the analgesic efficacy and safety of intravenous paracetamol, administered as propacetamol, in comparison with placebo and intramuscular diclofenac in patients with post-operative pain. METHODS: This was a randomized, double-blind, double-dummy study. One hundred and twenty patients with moderate to severe pain following total hip arthroplasty received either two administrations of propacetamol 2 g intravenously, 5 h apart (n = 40), one single administration of diclofenac 75 mg intramuscularly (n = 40) or placebo (n = 40). Efficacy measures were assessed before each drug administration, for the 5 h following each study treatment administration and for the total study duration of 10 h. Safety was assessed by reporting adverse events and changes in vital signs, electrocardiogram (ECG) and biochemical investigations before and 24 h after dosing. RESULTS: Both active treatments were effective and statistically superior to placebo over the whole study period, as indicated by the total pain relief score. No significant differences were found between propacetamol and diclofenac for any measures of analgesic activity. Only minor and common adverse events were reported, with no overall differences between the groups. CONCLUSION: Both active treatments were superior to placebo, and the overall efficacy of two intravenous infusions of propacetamol 2 g (equivalent to 1 g of paracetamol), 5 h apart, was not statistically different from that provided by a single intramuscular injection of diclofenac 75 mg over the first 5 h post-dose and over the total 10-h study period. The safety was good.     

Preoperative ketorolac administration has no preemptive analgesic effect for minor orthopaedic surgery

The utility of preoperative ketorolac administration to reduce the intensity and duration of postoperative pain was compared with placebo in a randomized double-blind design of 60 ASA 1–2 patients scheduled for minor orthopaedic surgery. No opioids nor local anaesthetic blocks were used during surgery. The patients received either 30 mg ketorolac IV before surgery followed by a placebo injection after surgery or the reverse. Postoperative pain intensity was assessed repeatedly for 6 h using a visual analogue scale. No differences in pain intensity were observed between the two groups except for the initial 15-min postoperative assesments in the ketorolac group. The time to first rescue morphine administration and the total morphine consumption during the 6-h observation period were similar. It is concluded that the preoperative administration of ketorolac did not provide a significant preemptive analgesic benefit with regard to postoperative pain relief and opioid dose-sparing effect.     

Combination tramadol plus acetaminophen for postsurgical pain

BACKGROUND: This multicenter, randomized, double-blind, active- and placebo-controlled trial evaluated tramadol plus acetaminophen (APAP) for orthopedic (n = 153) and abdominal (n = 152) postsurgical pain. METHODS: Patients with moderate pain or greater were randomized to an initial two tablets of 37.5 mg tramadol plus 325 mg APAP (n = 98), codeine 30 mg plus APAP 300 mg (n = 109), or placebo (n = 98); thereafter, they received 1 to 2 tablets every 4 to 6 hours as needed for pain for 6 days. Outcome measures were pain relief and pain intensity, total pain relief, sum of pain intensity differences, and sum of pain relief and pain intensity differences during 4 hours and the daily averages. RESULTS: Tramadol plus APAP was superior to placebo for total pain relief, sum of pain intensity differences, and sum of pain relief and pain intensity differences (P < or =0.015); tramadol plus APAP and codeine plus APAP did not separate (P > or=0.281). For average daily pain relief, average daily pain intensity, and overall medication assessment, tramadol plus APAP was superior to placebo (P < or =0.038); codeine plus APAP did not separate from placebo (P > or =0.125). Discontinuation because of adverse events occurred in 8.2% of tramadol plus APAP, 10.1% of codeine plus APAP, and 3.0% of placebo patients. Except for constipation (4.1% tramadol plus APAP vs 10.1% codeine plus APAP) and vomiting (9.2% vs 14.7%, respectively), adverse events were similar for active treatments. CONCLUSIONS: Tramadol plus APAP (mean dose 4.4 tablets) was effective and well tolerated for postsurgical pain and showed better tolerability than did codeine plus APAP.     

A prospective, randomized comparison of dexketoprofen, ketoprofen or paracetamol for postoperative analgesia after outpatient knee arthroscopy

BACKGROUND: This prospective, randomized study was conducted to evaluate the quality of postoperative pain relief when using dexketoprofen, ketoprofen, or paracetamol after outpatient knee arthroscopy. METHODS: Without premedication, 45 ASA physical status I-II patients undergoing elective outpatient knee arthroscopy with combined sciatic-femoral nerve block, were randomly allocated to receive either 25 mg oral dexketoprofen (n = 15), 50 mg oral ketoprofen (n = 15), or 500 mg oral paracetamol (n = 15) before block placement. After completion of surgery the same pain medication was given according to standard protocols, while 50 mg oral tramadol were allowed as rescue analgesic if required by the patient. After standard discharge criteria had been fulfilled, patients were discharged from the day-surgery unit, while a telephone follow-up was performed the day after surgery using standard questionnaires evaluating the quality of pain relief during the first 24 hours after surgery. Total consumption of rescue tramadol, maximum pain complained of after hospital discharge, as well as the visual analogue scale of pain measured at hospital discharge were assessed by an independent trained observer. RESULTS: No differences in anthropometric variables, duration of surgical procedure, and fulfillment of discharge criteria were observed between the three groups. The degree of pain measured at rest at hospital discharge was similar in the three groups, while the VAS measured during motion was higher in patients receiving paracetamol (24 +/- 2.5 mm) than in those patients treated with dexketoprofen (13 +/- 6 mm) or ketoprofen (17 +/- 5 mm) (p = 0.016). Two patients (one in ketoprofen group and one in paracetamol group) required rescue tramadol after hospital discharge; however, no differences in maximum pain complained of after surgery or patient acceptance were observed between groups. CONCLUSIONS: This prospective, randomized study demonstrated that in outpatients receiving arthroscopic knee surgery, the use of 75 mg/day dexketoprofen was as effective and safe as 150 mg/day racemate ketoprofen, with a better pain relief during motion compared to 2 g/day paracetamol when patients were discharged from the day-surgery unit.     

Effects of lidocaine aerosol on postoperative pain and wound tenderness following minor gynaecological laparotomy

Twenty-four female patients undergoing sterilization through a minor lower laparotomy received, in a double-blind, randomized study, either lidocaine spray 200 mg or placebo in the surgical wound. Postoperative pain intensity was evaluated on a verbal and a visual analogue scale and wound tenderness with an algometer. During mobilisation from the supine to the sitting position, VAS-score was lower (P less than 0.05) in the lidocaine group 2 h postoperatively, but not 4, 6 and 8 h postoperatively (P greater than 0.05). No significant differences were found in VAS-scores at rest or during cough, or in verbal scale ratings during rest, cough or mobilisation, and postoperative consumption of morphine was similar in the two groups. Pressure pain thresholds were higher (P less than 0.05) 2 h postoperatively in the lidocaine group, but not 4, 6 and 8 h postoperatively. In conclusion, topically applied lidocaine aerosol in the surgical wound leads to very short and clinically insignificant relief of postoperative pain.     

The clinical effect of ketoprofen after arthroscopic subacromial decompression: a randomized double-blind prospective study.

The purpose of the study was to evaluate the clinical effect of ketoprofen after arthroscopic subacromial decompression (ASD). The design was randomized, prospective, and double-blind, with a placebo control group. Forty-one consecutive patients with subacromial impingement syndrome, were randomized to treatment with ketoprofen 200 mg once daily or placebo for 6 weeks following ASD. For additional analgesia, patients used paracetamol if necessary. Clinical follow-up was performed at 6 weeks and at 2 years postoperatively. At the 6-week follow-up, the patients treated with ketoprofen had a statistically significant increase in UCLA total score (P<.05), range of movement (P<.05), and satisfaction (P<.05), and they had significantly less pain (P<.05). There was no statistical difference between the ketoprofen and placebo groups regarding strength. Patients receiving ketoprofen had significantly less need for additional analgesia (P<.05). At the 2-year follow-up, there were no differences in the scores between the ketoprofen and placebo group.     

The specific cox-2 inhibitor valdecoxib provides effective analgesia after inguinal hernia surgery

OBJECTIVE: To compare 3 oral analgesic doses--valdecoxib 20 mg, valdecoxib 40 mg and controlled-release diclofenac 75 mg--to placebo in the treatment of pain after inguinal herniorrhaphy. METHOD: An international multicenter double-blind placebo-controlled trial comparing parallel groups receiving oral valdecoxib 20 or 40 mg, controlled-release diclofenac 75 mg, or placebo every 12 hours over a period of 36 hours. The study enrolled 269 patients undergoing inguinal herniorrhaphy with spinal anesthesia. Pain intensity difference, the sum pain intensity difference, need for rescue medication, and overall patient satisfaction were compared. RESULTS: Valdecoxib 40 mg and controlled-release diclofenac 75 mg take every 12 hours provided similar analgesia that was significantly more efficacious than placebo as shown by the sum pain intensity difference at 12 hours. Both treatments decreased pain intensity in comparison with baseline throughout the study. Differences were significant in comparison with placebo at 8-10 hours through 24 hours of administration of the first dose. No significant differences between valdecoxib 20 mg and placebo were observed. The percentage of patients needing rescue medication was significantly lower in the valdecoxib 40 mg group (30% in that group vs. 52% for placebo), and that difference was not seen for any of the other groups. All treatments were well tolerated. CONCLUSIONS: Valdecoxib 40 mg and diclofenac 75 mg provided similar quality of analgesia for treating pain after inguinal herniorrhaphy.     

Double-blind placebo-controlled comparison of dezocine and morphine for post-operative pain relief

Dezocine, a new mixed agonist-antagonist-type opioid analgesic, was compared in a double-blind trial with placebo and 10 mg of morphine in 190 patients with acute postoperative pain. The medications were given intramuscularly. Dezocine was administered at three dose levels (5, 10, and 15 mg). Pain relief scores, sedation, and side effects were recorded at 15, 30, 60, 120 and 240 min after injection. Significantly higher pain relief scores (p less than 0.05) were reported for the groups receiving dezocine 10 and 15 mg than the placebo group at all observation times, except for dezocine 15 mg at four hours. Morphine produced significantly better pain relief than placebo only between the second and fourth hour after administration. Significantly better pain relief was obtained with dezocine (10 and 15 mg) than with morphine during the first hour. The mean four-hour cumulative pain relief scores (TOTPAR) were significantly (p less than 0.05) higher than placebo for all active treatment groups. Side effects were few with no significant differences between the treatment groups. Seventy-nine per cent of the patients in the dezocine 15 mg group, and 73, 68, 58 and 50 per cent respectively, of the patients in the dezocine 10 mg, dezocine 5 mg, morphine 10 mg and placebo group had a satisfactory clinical response. Significantly (p less than 0.05) more patients in the groups receiving dezocine 10 and 15 mg than in the placebo group had a satisfactory clinical response; the difference was not significant for the dezocine 5 mg and morphine 10 mg groups.(ABSTRACT TRUNCATED AT 250 WORDS)     

Rectal paracetamol has a significant morphine-sparing effect after hysterectomy

We have evaluated the morphine-sparing effect of rectal paracetamol during the first 24 h after abdominal hysterectomy in a placebo- controlled, double-blind study. We studied 72 patients receiving patient-controlled analgesia (PCA) with i.v. morphine after a standardized anaesthetic, allocated randomly to receive rectal paracetamol 1.3 g, diclofenac 50 mg or placebo, after wound closure and at 8 and 16 h. Suppositories were blinded by the hospital pharmacy. Study violations excluded data from seven patients. Patient data, morphine doses during anaesthesia and recovery, and sedation and nausea scores were comparable. Mean morphine consumption during PCA was 35.0 (SD 20.4) mg, 32.7 (27.4) mg and 54.9 (28.3) mg in the paracetamol (n = 24), diclofenac (n = 20) and placebo (n = 21) groups, respectively (P < 0.05). Morphine sparing during PCA for paracetamol and diclofenac (36% vs 40% over 24 h) was significant from 4 h. Global scores of average pain over 24 h were lower after diclofenac compared with paracetamol (P < 0.01) and placebo (P = 0.08). We conclude that rectal paracetamol was an efficacious adjuvant analgesic after regular dosing.      

Double-blind comparison of intravenous doses of dezocine, butorphanol, and placebo for relief of postoperative pain

The safety and efficacy of intravenous doses of dezocine (5 or 10 mg), butorphanol (1 mg), and placebo were compared in a double-blind study in 160 patients with moderate to severe postoperative pain. Analgesic efficacy was assessed for 6 hours after each dose. Mean pain relief scores were consistently higher, indicating greater pain relief, for the three active treatment groups than for the placebo group. The 10-mg dezocine dose was the most effective treatment, and 5 mg of dezocine was comparable to 1 mg of butorphanol. In the 2 hours after the first dose, 32% of the 10-mg dezocine group, 53% of the 5-mg dezocine group, 65% of the butorphanol group, and 88% of the placebo group withdrew from the study because of unsatisfactory pain relief. The differences in these percentages were statistically significant (P less than 0.05) between each active therapy group and the placebo group, and between the 10-mg dezocine group and the butorphanol group. Changes in degree of sedation were similar in the three active therapy groups. Adverse reactions were rare, mild, and equally distributed among the four treatment groups. We conclude that 10 mg of dezocine is superior to 1 mg of butorphanol, and that 5 mg of dezocine is as effective as 1 mg of butorphanol for the relief of moderate to severe postoperative pain.