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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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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:To investigate the efficacy of lubiprostone compared to Senna on bowel symptoms and constipation in post-operative orthopedic patients treated with opioids.In 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.64 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).Both lubiprostone and Senna improved constipation-related symptoms and QOL in opioid-induced constipation, with no significant between-group differences.

Project description:Pain control following painful orthopaedic procedures such as total knee arthroplasty (TKA) is an ongoing challenge, as current pain management techniques often result in under-medication and/or complications. In a study designed to test the effect of the micro-current skin patch (MCT) on pain relief in patients following TKA, we followed 24 patients, randomly divided into two groups, one group receiving MCT plus tramadol hydrochloride (tramadol) for pain relief and a control group receiving only tramadol, for 10 days postoperatively. Tramadol was given intramuscularly in increment doses of 100 mg, as needed, for the duration of the study period. Pain was assessed daily using a visual analogue score (VAS). Other parameters, including the effect of MCT on the dose of tramadol needed for pain relief, the degree of wound healing measured at the end of the follow-up period, category of the wound 10 days postoperatively (1, 2 or 3) and total drain fluid volume, were also assessed. During the 10-day postoperative period there was a progressive decrease in pain in patients of both groups, however the patients of the MCT group showed a consistently lower VAS throughout the observation period, most markedly on those follow-up days with the highest pain scores in patients of the control group. This effect was monitored on the basis of the average dose of tramadol administered per day: 200.0+/-7.0 mg/day in the control group and 63.3+/-15.8 mg/day in the MCT group. Wound healing was better with the application of the MCT patch: grade 1 wounds were observed in 50% of the patients of the MCT group as compared to 8.3% in control group. The total drain volume was lower in patients of the MCT group compared to the controls (1020.8+/-211.6 and 1170.8+/-243.5 ml, respectively). None of the patients indicated that they wished to discontinue MCT therapy. This pilot study shows that MCT therapy led to better pain control with a markedly lower need for tramadol as compared to the control group. This better pain control was accompanied by a better healing of the wound and a lower drain volume.

Project description:Focal cartilage injuries in the knee might have devastating effect due to the predisposition of early onset osteoarthritis. Various surgical treatment options are available, however no statistically significant differences have been found between the different surgical treatments. This supports the suggestion that the improvement might be a result of the post-operative rehabilitation rather than the surgery itself. Autologous chondrocyte implantation (ACI) has become a recognized treatment option for larger cartilage lesions in the knee. Although ACI has been compared to other surgical treatment such as microfracture and mosaicplasty, it has never been directly compared to simple arthroscopic debridement and rehabilitation alone. In this study we want to increase clinical and economic knowledge about autologous chondrocyte implantation compared to arthroscopic debridement and physical rehabilitation in the short and long run.We will conduct a randomized controlled trial to compare ACI with simple arthroscopic debridement (AD) and physiotherapy for the treatment of cartilage lesions in the knee. The study will include a total of 82 patients, both men and non-pregnant women, with a full thickness cartilage defect in the weight bearing area of the femoral condyles or trochlea larger than 2 cm2. The lesion must be symptomatic, with a Lysholm score less than 75. The two treatment groups will receive identical rehabilitation protocol according to a modification of Wondrasch et al., which is an active rehabilitation and education program divided into 3 phases: accommodation, rehabilitation and return to activity. The patients will be followed for 24 months, with additional late follow-ups at 5 and 10 years to monitor the potential onset of osteoarthtitis. The primary outcome measure will be the difference in the KOOS knee-related quality of life (QoL) subscore in the ACI group compared to the AD group at 2 years. A combination of self-explanatory questionnaires, clinical parameters, clinical hop tests and radiographs and Magnetic Resonance Imaging (MRI) will be used as secondary endpoints.This is the first study with a high level of evidence to compare ACI with simple debridement and physiotherapy for the treatment of isolated symptomatic full thickness lesions of the knee.ClinicalTrial NCT02636881 (21 December 2015).

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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.

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