Paracetamol versus Paracetamol Plus Ondansetron on Acute Postoperative Pain.
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ABSTRACT:
SUBMITTER: Aryafar M
PROVIDER: S-EPMC8674094 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundThere is good evidence that combining two different analgesics in fixed doses in a single tablet can provide better pain relief in acute pain and headache than either drug alone, and that the drug-specific benefits are essentially additive. This appears to be broadly true in postoperative pain and migraine headache across a range of different drug combinations, and when tested in the same and different trials. Adding caffeine to analgesics also increases the number of people obtaining good pain relief. Combinations of ibuprofen and caffeine are available without prescription in some parts of the world.ObjectivesTo assess the analgesic efficacy and adverse effects of a single oral dose of ibuprofen plus caffeine for moderate to severe postoperative pain, using methods that permit comparison with other analgesics evaluated in standardised trials using almost identical methods and outcomes.Search methodsWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the Oxford Pain Relief Database, two clinical trial registries, and the reference lists of articles. The date of the most recent search was 1 February 2015.Selection criteriaRandomised, double-blind, placebo- or active-controlled clinical trials of single dose oral ibuprofen plus caffeine for acute postoperative pain in adults.Data collection and analysisTwo review authors independently considered trials for inclusion in the review, assessed risk of bias, and extracted data. We used the area under the pain relief versus time curve to derive the proportion of participants with at least 50% pain relief over six hours prescribed either ibuprofen plus caffeine or placebo. We calculated the risk ratio (RR) and number needed to treat to benefit (NNT). We used information on the use of rescue medication to calculate the proportion of participants requiring rescue medication and the weighted mean of the median time to use. We also collected information on adverse effects.Main resultsWe identified five randomised, double-blind studies with 1501 participants, but only four had been published and had relevant outcome data. These four studies were of high quality, although two of the studies were small.Both ibuprofen 200 mg + caffeine 100 mg and ibuprofen 100 mg + caffeine 100 mg produced significantly more participants than placebo who achieved at least 50% of maximum pain relief over six hours, and both doses significantly reduced remedication rates (moderate quality evidence). For at least 50% of maximum pain relief, the NNT was 2.1 (95% confidence interval 1.8 to 2.5) for ibuprofen 200 mg + caffeine 100 mg (four studies, 334 participants) and 2.4 (1.9 to 3.1) for ibuprofen 100 mg + caffeine 100 mg (two studies, 200 participants) (moderate quality evidence). These values were close to those predicted by published models for combination analgesics in acute pain, and were supported by low (good) NNT values for prevention of remedication.Adverse event rates were low, and no sensible analysis was possible.Authors' conclusionsFor ibuprofen 200 mg + caffeine 100 mg particularly, the low NNT value is among the lowest (best) values for analgesics in this pain model. The combination is not commonly available, but can be probably be achieved by taking a single 200 mg ibuprofen tablet with a cup of modestly strong coffee or caffeine tablets. In principle, this can deliver good analgesia at lower doses of ibuprofen.
| S-EPMC6481458 | biostudies-literature
Project description:Postoperative nausea and vomiting (PONV) is one of the most common adverse outcomes after strabismus surgery. The primary outcome of this prospective, randomized, double-blind study was to compare the incidences of nausea or vomiting, and patient satisfaction of ondansetron and ramosetron after strabismus surgery under general anesthesia. The secondary outcome was to investigate whether the number of involved extraocular muscles (EOMs) in strabismus surgery was related to PONV.One hundred and five patients (aged 18-60 years) undergoing strabismus surgery were allocated randomly to one of the three groups: placebo, ondansetron, or ramosetron. Patients received 2 ml placebo, 4 mg ondansetron, or 0.3 mg ramosetron at the end of surgery. Each of the three groups was subdivided into two subgroups according to the number of EOMs involved in the surgery: subgroup S, single-muscle correction; subgroup M, multiple-muscle correction. The incidences of nausea or vomiting, and patient satisfaction at 2, 24 and 48 h after surgery were analyzed as primary outcome. With regard to subgroups S and M in the placebo, ondansetron and ramosetron groups, incidences of nausea or vomiting, and patient satisfaction at 2, 24 and 48 h after surgery were analyzed as seconadary outcome.The incidence of nausea was significantly lower in the ramosetron group at 2 h (9.4 %) than in the placebo (45.2 %) and ondansetron (34.7 %) groups (P < 0.05). The incidence of nausea was also significantly lower in the ramosetron group at 24 h than in the other groups (P < 0.05). Patients in the ramosetron group were more satisfied at 2 h (8.11 ± 0.98) and 24 h (8.50 ± 0.67) after surgery than those in the other groups (P < 0.05). With regard to subgroups S and M in the placebo, ondansetron and ramosetron groups, there were no significant differences in either the incidence of nausea or patient satisfaction.Ramosetron has superior antiemetic activity to ondansetron in adult strabismus surgery patients. The number of EOMs involved in strabismus surgery was not related to the incidence of PONV.Clinical Research Information Service (CRiS) Identifier: KCT0000688 . Date of registration: 27 February 2013.
| S-EPMC4957928 | biostudies-other
Project description:PurposeEffect size estimates of analgesic drugs can be misleading. Ibuprofen (400 mg, 600 mg, 800 mg), paracetamol (1000 mg, 500 mg), paracetamol 1000 mg/codeine 60 mg, and placebo were investigated to establish the multidimensional pharmacodynamic profiles of each drug on acute pain with calculated effect size estimates.MethodsA randomized, double-blind, single-dose, placebo-controlled, parallel-group, single-centre, outpatient, and single-dose study used 350 patients (mean age 25 year, range 18 to 30 years) of homogenous ethnicity after third molar surgery. Primary outcome was sum pain intensity over 6 h. Secondary outcomes were time to analgesic onset, duration of analgesia, time to rescue drug intake, number of patients taking rescue drug, sum pain intensity difference, maximum pain intensity difference, time to maximum pain intensity difference, number needed to treat values, adverse effects, overall drug assessment as patient-reported outcome measure (PROM), and the effect size estimates NNT and NNTp.ResultsIbuprofen doses above 400 mg do not significantly increase analgesic effect. Paracetamol has a very flat analgesic dose-response profile. Paracetamol 1000/codeine 60 mg gives similar analgesia as ibuprofen from 400 mg, but has a shorter time to analgesic onset. Active drugs show no significant difference in maximal analgesic effect. Other secondary outcomes support these findings. The frequencies of adverse effects were low, mild to moderate in all active groups. NNT and NTTp values did not coincide well with PROMs.ConclusionIbuprofen doses above 400 mg for acute pain offer limited analgesic gain. Paracetamol 1000 mg/codeine 60 mg is comparable to ibuprofen doses from 400 mg. Calculated effect size estimates and PROM in our study seem not to relate well as clinical analgesic efficacy estimators.Trial registrationNCT00699114.
| S-EPMC8585829 | biostudies-literature
Project description:Pain after laparoscopic cholecystectomy (LC) is multifactorial and usually not effectively treated. Rectus sheath block (RSB) has been proven to reduce the pain from midline abdominal incision and laparoscopic surgery. We investigated the preemptive analgesic effect of RSB after LC. In this prospective, randomized, single-center trial, 200 patients undergoing LC were randomized into preoperative RSB (pre-RSB) or postoperative RSB (post-RSB) group. An ultrasound-guided RSB was performed before skin incision in the pre-RSB group or after skin closure in the post-RSB group. The primary outcome was total rescue analgesic consumption at 24 h post-surgery. The secondary outcomes were cumulated rescue analgesic consumption and postoperative pain measured by numerical rating scale (NRS) at 0, 1, 2, 6, 9, 18, and 24 h post-surgery. Total rescue analgesic consumption at 24 h post-surgery was significantly lower in the pre-RSB group than in the post-RSB group (p = 0.020). The cumulated rescue analgesic consumption was significantly lower in the pre-RSB group than in the post-RSB group at 1 h (p = 0.023), 9 h (p = 0.020) and 18 h (p = 0.002) post-surgery. NRS was significantly lower in the pre-RSB group than in the post-RSB group at 0 h post-surgery (p = 0.023). The pre-RSB reduced the analgesic requirements in patients undergoing LC compared with the post-RSB.
| S-EPMC6679218 | biostudies-literature
Project description:Introduction: In clinical practice, inadequate pain inhibition leads to increased morbidity and mortality. Increased intracellular calcium, oxidants, and proinflammatory cytokines are known to play a role in the pathogenesis of postoperative pain. Therefore, we investigated the analgesic effects of benidipine, paracetamol, and benidipine-paracetamol combination (BPC) on postoperative and normal pain thresholds in rats. Material and methods: Sixty-four male albino Wistar rats weighing 285-295 g were used. The without-incision rats were divided into 4 subgroups: healthy control, benidipine alone, paracetamol alone, and BPC. The scalpel-incision rats were divided into 4 subgroups: scalpel incision, scalpel incision + benidipine, scalpel incision + paracetamol, and scalpel incision + BPC. Paw pain thresholds of rats were measured using a Basile algesimeter. Biochemical analyses were performed on the paw tissues of 6 rats randomly taken from the experimental groups, each containing 8 rats. Rats were sacrificed immediately after the measurements. After the pain threshold tests were finished, the paw tissues were removed and malondialdehyde (MDA), total glutathione (tGSH), cyclooxygenase (COX), and interleukin-6 (IL-6) levels were measured. Results: There was no significant difference between the groups in paw pain threshold and measured biochemical parameters in rats without incision. The decrease in the pain threshold of the incised paw was also best prevented by BPC, followed by benidipine and then paracetamol. Furthermore, increases in scalpel-incised paw tissue MDA, COX-2, and IL-6 levels and the decrease in tGSH were significantly suppressed by benidipine and BPC, while paracetamol could only significantly inhibit the increase in IL-6 production. Conclusion: The combination of the L-type Ca2+ channel blocker benidipine and paracetamol (BPC) may provide potent analgesia. Our experimental results support that BPC may be useful in the treatment of severe pain that cannot be adequately inhibited by paracetamol.
| S-EPMC10796563 | biostudies-literature
Project description:Introduction Orthognathic surgical procedures include a series of surgical operations in which interventions are applied to the maxilla, mandible, or both for occlusal or aesthetic concerns due to facial skeletal development deformities. Double-jaw surgeries have the highest pain scores, in which both maxilla and mandible bones are intervened. This study aimed to compare the efficacy of individual applications of paracetamol and tenoxicam with their combined application on postoperative pain and opioid consumption in patients undergoing double-jaw surgery. Methods In this randomized, double-blind study, 60 patients undergoing double-jaw surgery were allocated into three groups, with each having 20 patients: the paracetamol group, the tenoxicam group, and the paracetamol-tenoxicam combination group. Pain intensity was evaluated using the visual analogue scale (VAS) at intervals of 30 minutes, 60 minutes, 120 minutes, and again at the 24th postoperative hour. Additionally, the consumption of opioids and other rescue analgesics was documented over the 24-hour postoperative period. Results The VAS values at 30 minutes, 60 minutes, and 24 hours were lower in the paracetamol-tenoxicam group compared to the other groups (p<0.001). The need for a rescue analgesic drug in the first 24 hours was not observed in the tenoxicam and paracetamol-tenoxicam groups. Conclusion It was concluded that both tenoxicam and paracetamol-tenoxicam combinations, especially the tenoxicam-paracetamol combination, were good options for postoperative analgesia in patients with double-jaw surgery.
| S-EPMC10460537 | biostudies-literature
Project description:Objective:Postoperative nausea and vomiting (PONV) is a common problem associated with general anaesthesia. The incidence can be as high as 80% in high-risk patients. Our primary objective was to compare the efficacy of the combination of dexamethasone-ondansetron and dexamethasone-aprepitant in patients undergoing laparoscopic surgery. Methods:Seventy 18 to 60 years old patients scheduled for laparoscopic surgery were included in the study. Sixty-seven patients completed the study. Patients in the dexamethasone-aprepitant group (group DA, n=35) received 40 mg of aprepitant orally 1-2 hours before the induction of anaesthesia and 2 mL saline intravenously (iv) within the last 30 minutes of surgery; patients in the dexamethasone-ondansetron group (group DO, n=35) received oral placebo identical to aprepitant 1-2 hours before the induction of anaesthesia and 4 mg ondansetron iv within the last 30 minutes of surgery. All patients received 8 mg dexamethasone iv after the induction of anaesthesia. The primary outcome was a complete response (no postoperative nausea, retching and vomiting and no need for rescue antiemetic); the secondary outcomes were the incidence of nausea, retching, vomiting, the need of rescue antiemetic and opioid consumption within 24 hours after surgery. Results:A complete response was not significantly different between the groups (group DO: 67%, DA: 69%) at 24 hours (p=0.93). The incidence of PONV and postoperative opioid consumption was similar between the groups. Conclusion:The study was designed to evaluate whether the combination of dexamethasone-aprepitant is better than the combination of dexamethasone-ondansetron regarding the complete response for PONV in patients undergoing laparoscopic surgery. The results however showed that dexamethasone-aprepitant has not improved the complete response for PONV compared to dexamethasone-ondansetron.
| S-EPMC6157978 | biostudies-literature
Project description:BackgroundThis study compared palonosetron and ondansetron as rescue medications for postoperative nausea and vomiting (PONV) in patients who received prophylactic ondansetron. Although guidelines recommend use of an agent from a different class when prophylaxis has failed, palonosetron has unique properties relative to other serotonin 5-HT3 receptor antagonists. Prior trials assessing its use for rescue have had conflicting results. Although palonosetron has compared favorably with ondansetron for PONV prevention, the drugs have not been compared in the rescue setting of failure of 5-HT3 receptor antagonist prophylaxis.MethodsThis was a randomized, open-label, multicenter trial comparing the efficacy and safety of intravenous palonosetron 0.075 mg and intravenous ondansetron 4 mg in patients experiencing PONV following laparoscopic abdominal or gynecological surgery despite prophylactic ondansetron.ResultsOf 239 patients screened, 220 were enrolled and 98 were treated for PONV: 48 and 50 in the palonosetron and ondansetron arms, respectively. Complete control during 72 hours after study drug administration was achieved in 25.0% of palonosetron recipients and 18.0% of ondansetron recipients (95% confidence interval [CI], -9.2, 23.3; p = 0.40). Corresponding incidences of vomiting were 29.2% for palonosetron and 48.0% for ondansetron (95% CI, -0.06, 37.7; p = 0.057), and 62.5% and 56.0% required additional rescue treatment, respectively (95% CI, -25.9, 12.9; p = 0.52). Other than a similar incidence of procedural pain in the 2 groups, the most common treatment-emergent adverse events, which were generally mild, were headache (14.6% vs 12.0%), constipation (8.3% vs 10.0%), and dizziness (6.3% vs 8.0%), for the palonosetron and ondansetron groups, respectively.ConclusionsPalonosetron and ondansetron did not show differences in the primary efficacy endpoint of CC during the 72 hours after study drug administration. There was a trend toward less emesis in the 0-72 h time period favoring palonosetron. While larger studies are needed to fully assess any clinical benefits of palonosetron to rescue patients who have failed ondansetron prophylaxis for PONV, the benefit, if any, would be limited based on this study.Trial registrationClinicalTrials.gov, NCT00967499 (Registered August 27, 2009).
| S-EPMC4152758 | biostudies-literature
Project description:BackgroundEfficient pain management is one of the most important components of care in the field of emergency medicine.ObjectivesThis study was conducted to compare intravenous paracetamol and intravenous morphine sulfate for acute pain reduction in patients with limb trauma.Patients and methodsIn a randomized double-blinded clinical trial, all patients (aged 18 years and older) with acute limb trauma and a pain score of greater than 3/10 in the emergency department were recruited; they received either 1 g intravenous paracetamol or 0.1 mg/kg intravenous morphine sulfate over 15 minutes. The primary outcome was the pain score measured on a numerical rating scale at 0, 15 and 30 minutes after commencing drug administration. The requirement for rescue analgesia and the frequency of adverse reactions were also recorded.ResultsSixty patients randomly received either IV paracetamol (n = 30) or IV morphine (n = 30). The mean reduction in numerical rating scale pain intensity scores at 30 minutes was 3.86 (± 1.61) for paracetamol, and 2.16 (± 1.39) for morphine. However, pain relief was significantly higher in the paracetamol group compared to the morphine group (P < 0.001). Four patients in the paracetamol group and 15 patients in the morphine group needed rescue analgesia and the difference was significant (P = 0.05).ConclusionsIntravenous paracetamol appears to provide better analgesia than intravenous morphine in acute limb trauma. Further larger studies are required.
| S-EPMC4869432 | biostudies-literature
Project description:IntroductionChronic postsurgical pain (CPSP) is a global issue with high prevalence. This study compared acute pain descriptors among patients undergoing carpal tunnel release (CTR) or trigger finger release (TFR). We hypothesized worst pain intensity on postoperative day (POD) 10 would be best to predict the time to pain resolution.MethodsIn this secondary analysis of a negative, randomized, double-blind placebo-controlled trial, adult veterans undergoing CTR or TFR were enrolled January 2012-January 2014, with data analysis February 2020-October 2020. Participants were randomized to receive minocycline 200 mg or placebo 2 h prior to the operation, then minocycline 100 mg or placebo twice daily for 5 days. The Brief Pain Inventory, assessed daily, captured three pain scores: average and worst pain over the past 24 h, and current pain intensity. Fifteen acute pain descriptors based on the pain scores (clusters, mean, median, pain scores on POD 10, and linear slopes) were compared as predictors of time to pain resolution.ResultsOf 131 randomized participants, 114 (83 CTR, 31 TFR) were included. Average pain over the last 24 h reported on POD 10 best predicted time to pain cessation. Every one-point increase in the average pain score was associated with a 36.0% reduced rate of pain cessation (HR, 0.64, 95% CI 0.55-0.74, p < 0.001). Average pain on POD 10 was significantly associated with the development of CPSP at 90 days (OR 1.74, 95% CI 1.30-2.33, p value < 0.001). The optimal cutoff score for the high-risk group was determined as average pain on POD 10 ≥ 3.ConclusionsThis study validates prior work and demonstrates the importance of assessing pain severity on POD 10 to identify patients at high risk for CPSP who are most likely to benefit from early pain intervention. Future research in diverse surgical cohorts is needed to further validate pain assessment on POD 10 as a significant predictor of CPSP.
| S-EPMC8586397 | biostudies-literature