Effect of Intraoperative Paracetamol on Catheter-Related Bladder Discomfort: A Prospective,Randomized, Double-Blind Study

Background

The insertion of urinary catheters during urinary surgical interventions may lead to catheter-related bladder discomfort (CRBD) in the postoperative period.

Objective

We aimed to evaluate the effect of single-dose intravenous paracetamol on CRBD.

Methods

In this randomized, controlled, double-blind study, 64 patients (age >18 years, American Society of Anesthesiologists Physical Status I–II) requiring urinary bladder catheterization for percutaneous nephrolithotomy were assigned to groups that received either intravenous paracetamol (15 mg/kg) (group P) or NaCl 0.9% solution (control group [group C]) 30 minutes before the end of surgery. Patients received patient-controlled analgesia (10-mg bolus of meperidine, without infusion, 20-minute lock out) postoperatively. CRBD and pain status were assessed at 30 minutes and 1, 2, 4, 6, and 12 hours postoperatively. Postoperative meperidine requirement and patient and surgeon satisfaction were assessed.

Results

Group P had significantly lower CRBD scores at all time points except at 12 hours postoperatively compared with group C (P < 0.05). Total meperidine consumption was significantly higher in group C (P < 0.05). Patient and surgeon satisfaction scores were significantly higher in group P (P < 0.05).

Conclusions

Intraoperative single-dose paracetamol was found to be effective in reducing the severity of CRBD and pain in urologic surgery. We suggest that it may be an efficient, reliable, easy-to-apply drug for CRBD. ClinicalTrials.gov identifier: NCT01652183.     

Catheter‐Associated Urinary Tract Infections: A Nurse‐Sensitive Indicator in an Inpatient Rehabilitation Program

Urinary tract infections account for 40% of all hospital‐acquired infections; 80% of those infections are associated with indwelling urethral catheters. To meet the requirement for medical necessity, patients are being admitted to rehabilitation programs earlier in their hospital stays than in the past. As a result, there has been an increase in the use of urinary catheters, which prompted an evaluation of infection rates. A collaborative project between nursing and infection control was designed to collect baseline data on catheter‐associated urinary tract infections (CAUTI) in a nonintensive care unit inpatient setting. Two inpatient rehabilitation units within our health system participated. The purpose of this article is to share the process used to determine a baseline CAUTI rate, the interventions implemented to reduce use of catheters, and the outcomes associated with this project. The results demonstrate an overall reduction in the use of catheters, as well as a reduction in CAUTI.     

Subdissociative‐dose Ketamine versus Fentanyl for Analgesia during Propofol Procedural Sedation: A Randomized Clinical Trial

Objectives: The authors sought to compare the safety and efficacy of subdissociative‐dose ketamine versus fentanyl as adjunct analgesics for emergency department (ED) procedural sedation and analgesia (PSA) with propofol. Methods: This double‐blind, randomized trial enrolled American Society of Anesthesiology (ASA) Class I or II ED patients, aged 14–65 years, requiring PSA for orthopedic reduction or abscess drainage. Subjects received 0.3 mg/kg ketamine or 1.5 μg/kg fentanyl intravenously (IV), followed by IV propofol titrated to deep sedation. Supplemental oxygen was not routinely administered. The primary outcomes were the frequency and severity of cardiorespiratory events and interventions, rated using a composite intrasedation event rating scale. Secondary outcomes included the frequency of specific scale component events, propofol doses required to achieve and maintain sedation, times to sedation and recovery, and physician and patient satisfaction. Results: Sixty‐three patients were enrolled. Of patients who received fentanyl, 26/31 (83.9%) had an intrasedation event versus 15/32 (46.9%) of those who received ketamine. Events prospectively rated as moderate or severe were seen in 16/31 (51.6%) of fentanyl subjects versus 7/32 (21.9%) of ketamine subjects. Patients receiving fentanyl had 5.1 (95% confidence interval [CI] = 1.9 to 13.6; p < 0.001) times the odds of having a more serious intrasedation event rating than patients receiving ketamine. There were no significant differences in secondary outcomes, apart from higher propofol doses in the ketamine arm. Conclusions: Subdissociative‐dose ketamine is safer than fentanyl for ED PSA with propofol and appears to have similar efficacy.     

Measures of Functioning in Patients With Episodic Migraine: Findings From a Double‐Blind,Randomized, Placebo‐Controlled Phase 2b Trial With Galcanezumab

Objective – To evaluate 12‐week changes from baseline of 2 disease‐specific patient‐reported outcome (PRO) measures in adults with migraine treated with galcanezumab, an investigational humanized antibody binding calcitonin gene‐related peptide (CGRP), or placebo. Background – Preventing headache‐related functional impairment is an important goal of migraine preventive treatment and a measurement target for PROs. Understanding which drugs have the potential to improve patient functioning in addition to preventing migraine headaches is vital to lessening patient burden. Design/Methods – This Phase 2b double‐blind, randomized, placebo‐controlled study enrolled adults with episodic migraine. Galcanezumab (120 mg subcutaneous injection; n = 60) or placebo (n = 127) was administered every 28 days for 12 weeks. Post hoc secondary analyses were conducted for those who completed 12 weeks of treatment on 2 PROs: The Migraine‐Specific Quality of Life Questionnaire (MSQ) v2.1 and the Headache Impact Test? (HIT‐6). Results – Analysis of covariance revealed significant differences in least square mean changes from baseline between galcanezumab and placebo for all MSQ domains including total mean change placebo of 18.63, galcanezumab of 27.36 (95% CI 2.449, 15.008; P‐value of .0067); Role Function‐Restrictive mean change placebo of 22.40, galcanezumab of 31.92 (95% CI 2.636, 16.518; P‐value of .0071); Role Function‐Preventive mean change placebo of 13.43, galcanezumab of 19.76 (95% CI 0.476, 12.185; P‐value of .0342); and Emotional Function mean change placebo of 16.88, galcanezumab of 26.61 (95% CI 2.789, 16.674; P‐value of .0063). At baseline, mean number of migraine headache days (MHDs) did not correlate with MSQ total scores or HIT‐6. At 12 weeks post‐treatment, MHD correlated with MSQ and HIT‐6 scores (all P < .0001). Change in MHD was associated with change in MSQ domains and change in HIT‐6 scores (all P < .0001). Conclusions – In comparison with placebo, treatment with galcanezumab was associated with significant functional improvements as reflected by changes in MSQ scores. Change in MHD was associated with improvements in MSQ and reductions in HIT‐6 scores, indicating the clinical importance of these changes in relation to PROs that measure function.     

Slow Infusion of Low‐dose Ketamine Reduces Bothersome Side Effects Compared to Intravenous Push: A Double‐blind,Double‐dummy,Randomized Controlled Trial

Objective

We compared the analgesic efficacy and incidence of side effects when low‐dose (0.3 mg/kg) ketamine (LDK) is administered as a slow infusion (SI) over 15 minutes versus an intravenous push (IVP) over 1 minute.

Methods

This was a prospective, randomized, double‐blind, double‐dummy, placebo‐controlled trial of adult ED patients presenting with moderate to severe pain (numerical rating scale [NRS] score ≥ 5). Patients received 0.3 mg/kg ketamine administered either as a SI or a IVP. Our primary outcome was the proportion of patients experiencing any psychoperceptual side effect over 60 minutes. A secondary outcome was incidence of moderate or greater psychoperceptual side effects. Additional outcomes included reduction in pain NRS scores at 60 minutes and percent maximum summed pain intensity difference (%SPID).

Results

Fifty‐nine participants completed the study. A total of 86.2% of the IVP arm and 70.0% of the SI arm experienced any side effect (difference = 16.2%, 95% confidence interval [CI] = –5.4 to 37.8). We found a large reduction in moderate or greater psychoperceptual side effects with SI administration—75.9% reported moderate or greater side effects versus 43.4% in the SI arm (difference = 32.5%, 95% CI = 7.9 to 57.1). Additionally, the IVP arm experienced more hallucinations (n = 8, 27.6%) than the SI arm (SI n = 2, 6.7%, difference = 20.9%, 95% CI = 1.8 to 43.4). We found no significant differences in analgesic efficacy. At 60 minutes, the mean %SPID values in the IVP and SI arms were 39.9 and 33.5%, respectively, with a difference of 6.5% (95% CI = –5.8 to 18.7).

Conclusion

Most patients who are administered LDK experience a psychoperceptual side effect regardless of administration via SI or IVP. However, patients receiving LDK as a SI reported significantly fewer moderate or greater psychoperceptual side effects and hallucinations with equivalent analgesia.

     

术前护理干预对术后尿管刺激征耐受的影响

目的 观察术前对神经外科手术患者实施导尿护理干预,对患者麻醉苏醒期及术后尿管刺激征耐受程度的影响.方法 将95例手术前患者随机分为干预组（n=47）和对照组（n=48）.两组患者均在手术室全麻后留置尿管,干预组患者术前1 d接受护理干预,对照组接受传统的术前导尿健康教育.术后测评两组患者麻醉苏醒期、意识清醒期的尿管刺激征程度,术后患者自测尿管刺激征程度,记录患者意外拔除尿管的例数.结果 两组患者尿管刺激征得分麻醉苏醒期差异无统计学意义,意识清醒期干预组得分低于对照组;患者自测得分及意外拔除尿管例数,两组差异无统计学意义.结论 术前实施导尿护理干预有效帮助患者应对意识清醒期的尿管刺激征,增强患者的耐受能力.     

A Multicenter,Randomized, Double‐Blind,Placebo‐Controlled Trial of Intravenous Ibuprofen (IV‐Ibuprofen) in the Management of Postoperative Pain Following Abdominal Hysterectomy

Background: Ibuprofen and other nonsteroidal anti‐inflammatory drugs are widely used to block pain and inflammation in a variety of settings. Contrarily, opioid analgesia does not block the inflammatory component of pain and the use of these agents can be accompanied by serious side effects. We conducted a multicenter, randomized, double‐blind, placebo‐controlled trial to evaluate the safety and efficacy of intravenous ibuprofen (IV‐ibuprofen) as a postoperative analgesic. Methods: A total of 319 patients were randomly assigned in a 1:1 ratio to receive 800 IV‐ibuprofen or placebo every 6 hours; in addition patients had access to morphine at a dose of 1–2 mg every 5 minutes. The primary outcome measure was median morphine consumption within the first 24 hours following surgery. Results: During the first 24 hours of treatment, the median morphine requirement was reduced by 19% (P ≤ 0.001) and resulted in a significant reduction in pain at rest (AUC, 6 to 24 hours and 12 to 24 hours, P < 0.001) and pain with movement (AUC, 6 to 24 hours, P = 0.010 and 12 to 24 hours, P ≤ 0.001) as measured by the visual analog scale (VAS) in patients receiving 800 mg IV‐ibuprofen compared to placebo. Time to ambulation was significantly faster (P = 0.018) in the IV‐ibuprofen treated group, as well. Similar treatment‐emergent adverse events occurred across both study groups and there was no difference in the overall incidence of these events. Conclusion: This study demonstrated that IV‐ibuprofen is an effective analgesic medication that is safe and well tolerated when administered as an 800 mg dose every 6 hours in patients undergoing total abdominal hysterectomy surgery.     

A Randomized Double‐Blind Study Comparing Rizatriptan,Dexamethasone, and the Combination of Both in the Acute Treatment of Menstrually Related Migraine

Objectives.— To assess the efficacy and tolerability of rizatriptan (RI), dexamethasone (DE), and RI combined with DE (RI+DE) in the acute treatment of menstrually related migraine (MRM). Methods.— This was a randomized, double‐blind, 6‐attack crossover study comparing RI 10 mg, DE 4 mg, and RI+DE (2 attacks each). The primary endpoint was 24‐hour sustained‐relief. The secondary endpoint was 24‐hour sustained pain‐free. We treated the primary and secondary endpoint as dichotomous outcomes and used matched nonparametric statistics to assess proportions. We used logistic regression to determine the effect of treatment order and if response to previous treatment influenced treatment response. Results.— A total of 35 patients treated 190 attacks (mean of 5.4 per participant). For the primary endpoint, RI was significantly superior to DE (62.7% vs 33.3%, P = .001). RI+DE was superior to RI (81.5% vs 62.7%, P < .05) and to DE (81.5% vs 33.3%%, P < .001). For the secondary endpoint RI was also superior to DE (32.2% vs 12.1%, P < .05). RI+DE was superior to RI (50.7% vs 32.2%, P < .05) and DE (P < .01, RR). Similar findings were seen for the other endpoints. More attacks treated with DE+RI (33.8%) were associated with side effects, compared to RI (18.6%) and DE (15.2%). Conclusions.— Rizatriptan is an effective treatment for MRM. RI+DE is significantly more effective than RI alone, although is associated with higher rate of adverse events. The combination should be considered for subjects with high disability, incomplete relief, or recurrence of pain with triptan monotherapy. The use of DE alone in the treatment of MRM is not justified based on our data.     

Prophylactic Etoricoxib Is Effective in Preventing Yom Kippur Headache: A Placebo‐Controlled Double‐Blind and Randomized Trial of Prophylaxis for Ritual Fasting Headache

(Headache 2010;50:1328‐1334) Background.— Religious fasting is associated with headache. This has been documented as “Yom Kippur Headache” and “First‐of‐Ramadan Headache.” Rofecoxib (Vioxx®), a cyclooxygenase‐2 (Cox‐2) inhibitor with a 17‐hour half‐life, has been shown to be effective in preventing fasting headache when taken just prior to the 25‐hour Yom Kippur fast. Unfortunately for fasters rofecoxib is no longer available. We hypothesized that etoricoxib, another Cox‐2 inhibitor with a longer half‐life, would also be effective in preventing fasting headache. Methods.— We performed a double‐blind randomized prospective trial of etoricoxib 120 mg vs placebo, taken just prior to the onset of fasting, Yom Kippur 2008. Healthy adults aged 18‐65 years were enrolled from the community. Subjects completed a demographic data form and questions regarding headache history and a post‐fast survey on headache during the fast. We compared incidence, time of onset and intensity of headache, general ease of fasting, and side effects in control and treatment groups. Results.— We enrolled 211 patients and 195 completed the post‐fast questionnaire (92%). Of those subjects receiving etoricoxib (n = 99), 36 or 36.4% vs 65 or 67.7% of the placebo group (n = 96) developed any headache during the fast (P < .0001). Median severity of headache in the treatment group was significantly lower for the treatment group (3.0 vs 5.0 on a visual analog scale of 10; P = .024). Also, participants in the treatment group reported an easier fast than the placebo group, as compared with previous fasting experience (4.0 vs 3.5 on a scale of 1‐5; P < .0001). Conclusion.— Etoricoxib 120 mg taken prior to a 25‐hour ritual fast decreases incidence of and attenuates fasting headache. NCT number is NCTT00752921.     

Analgesic Effectiveness of Dipyrone (Metamizol) for Postoperative Pain after Herniorrhaphy: A Randomized,Double‐Blind,Dose–Response Study

Background: The efficacy of non‐narcotic analgesics is mostly supported by randomized, placebo‐controlled trials with no comparison with ordinary practice. Additionally, systematic reviews of these placebo‐controlled trials have failed to determine clinically meaningful dose–response effect. Methods: In this double‐blind, randomized trial, patients undergoing elective inguinal, umbilical or epigastric herniorrhaphy under general anesthesia were assigned to receive 15 mg/kg (D15 group) vs. 40 mg/kg (D40 group) of dipyrone intravenously during surgery. The primary outcome was the incidence of moderate to severe pain with movement during the recovery room phase. The secondary outcomes were morphine consumption, incidence of vomiting, and Ramsay score (sedation scale). Results: One hundred sixty‐two patients were enrolled and analyzed for the primary and secondary outcomes. Relative to the D15 group, the D40 group showed a lower incidence of moderate to severe pain in the first 30 minutes (61% and 40%; P value < 0.05); lower cumulative morphine consumption during the recovery period (3.85 vs. 2.55 mg, P value < 0.006) as well as a lower incidence of vomiting (15.8% vs. 2.5%, P value < 0.005). In addition, more cases of sedation were recorded in the D15 group than in the D40 group (17 vs. 10 cases). There were no serious adverse effects attributed to dipyrone in either group. Conclusion: This trial shows a dose–response effect of 40 mg/kg over 15 mg/kg of intravenous dipyrone based on better movement‐induced pain control, lower morphine consumption and fewer opioid‐related side effects.     

Effect of Ketamine Added to Ropivacaine in Nerve Block for Postoperative Pain Management in Patients Undergoing Anterior Cruciate Ligament Reconstruction: A Randomized Trial

PurposeNerve blocks are commonly used as a part of multimodal pain relief. It was previously shown that ketamine could enhance the analgesic effect of local anesthetics in nerve blocks. A literature review on adding ketamine to local anesthetics for ameliorating analgesia revealed inconsistencies in analgesic efficiency and safety. This prospective, randomized, double-blind trial was performed to evaluate the antinociceptive effect of mixing ketamine with local anesthetics in a combined femoral and sciatic nerve block (CFSNB) during anterior cruciate ligament (ACL) reconstruction.MethodsSeventy-six patients undergoing preoperative ultrasound-guided CFSNB in ACL reconstruction were enrolled. Patients were randomly assigned to 3 groups: Group RNK received perineural administration of 40-mg ketamine plus 0.375% ropivacaine in 40-mL volume; Group RIK received 40 mL of 0.375% ropivacaine, as well as IV ketamine 40 mg; and Group R received 40 mL of 0.375% ropivacaine. Pain scores were recorded. AUC was calculated based on the pain scores at different times. Duration of CFSNB, postoperative analgesic demand, time to first analgesic demand, and adverse events were also examined.FindingsPerineural ketamine decreased pain scores 20 and 24 h' postoperatively, as well as lowered AUC values (all, P = 0.001). Group RNK had a prolonged time to first analgesic request (P = 0.014), inhibited rebound pain (P = 0.001), and increased satisfactory score at 48 h’ postsurgery (P = 0.001). Perineural ketamine prolonged the duration of sensory block (P = 0.001) with no effect on early mobilization. There were no significant differences between Group R and Group RIK in terms of postoperative pain scores, AUC of different time intervals (P = 0.832 or more), and time to first rescue analgesics (P = 0.585). Compared with the 2 other groups, IV ketamine had a higher incidence of hallucination after operations.ImplicationsPerineural ketamine added to the ropivacaine-enhanced analgesic efficacy of CFSNB with less rebound pain compared with the IV ketamine and control groups. IV ketamine had no effect in potentiating analgesia when a conventional multimodal approach was used in the study. Chinese Clinical Trial Registry: ChiCTR1900023867.