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Comparing the Efficacy of IV Ibuprofen and Ketorolac in the Management of Postoperative Pain Following Arthroscopic Knee Surgery. A Randomized Double-Blind Active Comparator Pilot Study.

ABSTRACT: Introduction: Acute postoperative pain following knee arthroscopy is common in orthopedic surgeries. Managing pain postoperatively combines usage of opioids and non-steroidal anti-inflammatory drugs. The aim of this clinical study was to assess the efficacy of two different analgesic treatment regimens: intravenous (IV) ibuprofen and IV ketorolac for the treatment of postoperative pain pertaining to arthroscopic knee surgery. Methods: This was a single center, randomized, double-blind, parallel, active comparator clinical pilot study. Subjects were randomized to receive either IV ibuprofen, administered as two 800 mg doses or IV ketorolac, administered as a single 30 mg dose. Subjects in the ibuprofen group received 800 mg of IV ibuprofen within 2 h prior to surgery and a repeated second dose 4 h after the initial dose if they had not been discharged. Subjects in the ketorolac group received IV ketorolac 30 mg at the end of surgery, as per the manufacturer's recommendations. Pain assessments and opioid consumption data were collected up to 24 h postoperatively. Results: Of 53 randomized subjects, 51 completed the study. There were 20 subjects in the ibuprofen group and 31 subjects in the ketorolac group. The median (IQR) visual analog scale (VAS) pain score at resting upon post-anesthesia care unit (PACU) arrival was 33 (12, 52) vs. 9 (2, 25) (p = 0.0064) for the ketorolac and ibuprofen group, respectively. The median (IQR) visual analog scale (VAS) pain score at movement upon PACU arrival was 38 (20, 61) vs. 15 (6, 31) (p = 0.0018) for the ketorolac and ibuprofen group, respectively. Median VAS pain scores during movement taken at subsequent 30 min intervals in the ibuprofen group were less than half that of those reported in the ketorolac group for up to 90 min after arriving in PACU. The median VAS pain scores at rest and movement in the course of 120 min-24 h after PACU arrival was not statistically significant in both groups. Rescue opioid medication during PACU stay was required in 55.0% (N = 11) and 83.9% (N = 26), with a mean amount of narcotic consumption (oral morphine conversion) of 5.53 ± 5.89 mg vs. 19.92 ± 15.63 mg for the ibuprofen and ketorolac group, respectively (P < 0.001). However, opioid consumption during the first 24 h after PACU discharge was not statistically significant (p-value = 0.637). The mean time to first rescue medication was 77.62 ± 33.03 and 55.78 ± 35.37 for the ibuprofen and ketorolac group, respectively (p-value = 0.0456). There were no significant differences in patient satisfaction and documented adverse events during the first 24 h. Conclusion: This pilot study showed that the use of preemptive IV ibuprofen 800 mg could be considered to reduce postoperative pain and opioid consumption. Future prospective clinical trials using similar regimens should be conducted in order to gain a better understanding of how to best provide perioperative analgesic regimens. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT01650519.

SUBMITTER: Uribe AA

PROVIDER: S-EPMC6178884 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Comparing the Efficacy of IV Ibuprofen and Ketorolac in the Management of Postoperative Pain Following Arthroscopic Knee Surgery. A Randomized Double-Blind Active Comparator Pilot Study.

Uribe Alberto A AA Arbona Fernando L FL Flanigan David C DC Kaeding Christopher C CC Palettas Marilly M Bergese Sergio D SD

Frontiers in surgery 20181003

<b>Introduction:</b> Acute postoperative pain following knee arthroscopy is common in orthopedic surgeries. Managing pain postoperatively combines usage of opioids and non-steroidal anti-inflammatory drugs. The aim of this clinical study was to assess the efficacy of two different analgesic treatment regimens: intravenous (IV) ibuprofen and IV ketorolac for the treatment of postoperative pain pertaining to arthroscopic knee surgery. <b>Methods:</b> This was a single center, randomized, double-bl ...[more]

PMID: 30338261

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Project description:IntroductionIbuprofen acid is poorly soluble in the stomach, thus reaching maximum plasma levels at approximately 90 min post-dose. Ibuprofen lysinate has been developed to accelerate absorption of ibuprofen to shorten the time to analgesic efficacy. This study compared analgesic efficacy and onset of effect of a single dose of ibuprofen lysinate or ibuprofen acid in patients undergoing third molar extraction.MethodsRandomized, double-blind, placebo-controlled, multi-center, parallel-group single-dose study. Adults (18-60 years) undergoing extraction of ≥ 1 third molar were randomized 2:2:1 to ibuprofen lysinate, ibuprofen acid, or placebo postoperatively. Pain relief (PAR, 5-point scale, 0 = none to 4 = complete pain relief) and pain intensity (PI, 100 mm visual analog scale) were assessed between 15 and 360 min post-dose. The primary endpoint was the weighted sum of PAR scores at 6 h (TOTPAR). Time to onset of effect, global assessment of efficacy, and adverse events were also assessed.ResultsOverall, 351 patients received ibuprofen lysinate (N = 141), ibuprofen acid (N = 139), or placebo (N = 71). Both active treatments significantly reduced pain compared with placebo, from 15 min post-dose to 6 h (TOTPAR: ibuprofen lysinate: 19.57; ibuprofen acid: 19.96; placebo: 8.27). Ibuprofen lysinate was significantly more effective than placebo, but non-inferior to ibuprofen acid, at providing pain relief over 6 h. There was no significant difference between ibuprofen lysinate and ibuprofen acid for onset of analgesia. Both ibuprofen formulations were well tolerated; all adverse events were mild to moderate and considered unrelated to treatment.ConclusionsA single dose of ibuprofen lysinate is non-inferior to ibuprofen acid in terms of analgesic efficacy, onset of action, and tolerability in patients who have recently undergone dental surgery.Trial registrationEudraCT No. 2006-006942-33. Plain language summary available for this article.

Project description:AimTo investigate the efficacy of lubiprostone compared to Senna on bowel symptoms and constipation in post-operative orthopedic patients treated with opioids.MethodsIn this double blind, randomized, active comparator trial, adults who required opioids for analgesia following orthopedic procedures and who were admitted in inpatient rehabilitation were randomized following baseline assessments to lubiprostone (Amitza(®)), orally twice a day or Senna (generic) two capsules administered daily for six days. Subjects were assessed using the patient assessment of constipation (PAC)-symptoms (PAC-SYM) and the PAC-quality of life (PAC-QOL) scales measured at baseline and Day 7; Subjects were assessed daily for secondary measures included the Bristol stool scale bowel consistency, specific bowel symptom score (Nausea, cramping, straining, completeness, abdominal pain, time per lavatory attempt, assistance needed), adverse events and rescue medications required. Function was measured using the functional independence measure (FIM) at admission and discharge; length of stay (LOS) and missed treatments due to gastrointestinal symptoms were also assessed.Results64 adults were enrolled; 56 participants (28 in each group) had baseline and follow up measures and were included in the intention to treat (ITT) analyses. 43 participants completed the study, 21 in the active lubiprostone and 22 in the active Senna group. The mean age of the participants was 71.5 years (SD = 11.4 years, range: 28-96 years). In the ITT analyses, participants showed significant improvement in bowel symptoms as measured by the PAC-SYM (mean ± SD, -0.28 ± 0.60, range: -1-2.33) and PAC-QOL (mean ± SD, 0.33 ± 0.81, range: -1.5-2.0) over time, but there were no significant differences between the lubiprostone and Senna groups in mean change in the PAC-SYM (-0.20 ± 0.60 vs -0.36 ± 0.61, P = 0.61 respectively) or the PAC-QOL (0.29 ± 0.76 vs 0.37 ± 0.87, P = 0.61 respectively). The mean change in each bowel symptom also did not significantly differ between treatment groups on ITT analyses, except for completeness of bowel movement, with the Senna group showing greater negative mean change in bowel movement completeness (-0.56 ± 1.01 vs -2.00 ± 1.41, P = 0.03) and for reduction of abdominal pain, favoring Senna (-0.14 ± 0.73 vs -0.73 ± 1.08, P = 0.04). Fifteen (75%) participants in the lubiprostone and in the Senna group requested rescue treatments. Participants made significant functional improvement from admission to discharge over a median LOS of 12 d, with a mean FIM change of 29.13 ± 13.58 and no significant between group differences (27.0 ± 9.2 vs 31.5 ± 16.6, P = 0.27).ConclusionBoth lubiprostone and Senna improved constipation-related symptoms and QOL in opioid-induced constipation, with no significant between-group differences.

Dataset Information

Comparing the Efficacy of IV Ibuprofen and Ketorolac in the Management of Postoperative Pain Following Arthroscopic Knee Surgery. A Randomized Double-Blind Active Comparator Pilot Study.

Publications

Comparing the Efficacy of IV Ibuprofen and Ketorolac in the Management of Postoperative Pain Following Arthroscopic Knee Surgery. A Randomized Double-Blind Active Comparator Pilot Study.

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