Project description:ObjectivesThe objective of this study was to identify differences in pain perception and satisfaction with pain control in women receiving nonsteroidal anti-inflammatory drugs postoperatively.MethodsThis was a prospective, randomized controlled trial including urogynecology surgical patients. After surgery, all patients were randomized to receive either intravenous (IV) ketorolac or ibuprofen. The patients completed 3 visual analog scales (VAS) assessing pain at rest, pain with ambulation, and satisfaction with pain control. Postoperative opioid use was also measured.ResultsA total of 224 patients (112 in each arm) were included. Pain scores (SD) at rest in all patients who received ketorolac versus those who received ibuprofen was 2.30 (2.1) versus 2.68 (2.34) (P = 0.20). Pain scores (SD) with ambulation was 3.94 (2.57) versus 4.16 (2.73) (P = 0.57) in patients who received ketorolac and ibuprofen, respectively. Patients who received ketorolac rated their satisfaction with their pain regimen similarly to those who received ibuprofen (P = 0.50). The average amount (SD) of hydromorphone used in the ketorolac and ibuprofen arm was 3.68 (4.58) mg and 4.04 (4.97) mg, respectively (P = 0.58). A subgroup analysis based on type of surgery showed decreased pain at rest (VAS, 2.77 vs 4.88; P = 0.04) and increased satisfaction (VAS, 1.69 vs 4.67; P = 0.003) in patients who had laparotomy and received ketorolac.ConclusionsThere was no difference in pain and satisfaction with IV ketorolac compared with IV ibuprofen in patients who underwent all modalities of urogynecologic surgery. A subgroup of patients who underwent laparotomy had less pain with ketorolac.
Project description:Postoperative pain relief in 40 children undergoing elective infraumbilical surgery was assessed after caudal epidural adminstration of either lignocaine or bupivacaine in the doses of 0.5 mL/kg body weight of a 1 per cent solution and 0.5 mL/kg body weight of a 0.25 per cent solution respectively. Pain free period was assessed by subjective pain scales. The pain free period was significantly prolonged in children who were given bupivacaine (14.75 ± 2.75 hours) as compared to lignocaine (7.25 ± 3.25 hours).
Project description:Effective perioperative analgesia is lacking for children owing to interindividual variations and underdosing of opioids caused by fear of adverse effects. We investigated the role of COMT SNPs on postoperative pain management in children.One hundred and forty nine children undergoing adenotonsillectomy were enrolled. The associations of four COMT SNPs (rs6269, rs4633, rs4818 and rs4680) with postoperative pain were analyzed and outcome measures included maximum pain scores, need for postoperative opioid interventions and postoperative morphine requirements.We detected an association of postoperative opioid intervention need with all four COMT SNPs. Minor allele carriers of COMT SNPs were approximately three-times more likely to require analgesic interventions than homozygotes of major alleles (p-value range: 0.0031-0.0127; odds ratio range: 2.6-3.1). In addition, significant association was detected between maximum Face, Leg, Activity, Consolability, Cry (FLACC) pain scores and three COMT SNPs (rs6269, rs4633 and rs4680). Haplotype 1 (ATCA: 51.3%) and Haplotype 2 (GCGG: 36.2%) are more frequent. Haplotype 2 was associated with higher odds of intravenous analgesic intervention need in postanesthesia recovery unit with an odds ratio of 2.6 (95% CI: 1.2-5.4; p-value = 0.022).COMT SNPs may play a significant role in interindividual variation in postoperative pain perception and postoperative morphine requirements in children. Original submitted 16 August 2013; Revision submitted 13 December 2013.
Project description:BackgroundNonsteroidal antiinflammatory drugs, the most commonly used analgesics, reduce pain not only by inhibiting cyclooxygenase at peripheral sites of inflammation but also by potentially inhibiting cyclooxygenase in the central nervous system, especially the spinal cord. Animal studies suggest that products of cyclooxygenase in the spinal cord do not alter pain responses to acute noxious stimuli but reduce pain and sensitization after peripheral inflammation. We used a spinal injection of small doses of the cyclooxygenase inhibitor ketorolac to survey the role of spinal cyclooxygenase in human experimental pain and hypersensitivity states.MethodsAfter regulatory agency approval and informed consent, we examined the effect of 2.0 mg intrathecal ketorolac in 41 healthy volunteers to acute noxious thermal stimuli in normal skin and to mechanical stimuli in skin sensitized by topical capsaicin or ultraviolet burn. We also examined the effect of intravenous ketorolac.ResultsIntrathecal ketorolac reduced hypersensitivity when it was induced by a combination of ultraviolet burn plus intermittent heat and, according to one of the two analytical strategies, when it was induced by ultraviolet burn alone.ConclusionsThese data suggest a more limited role for spinal cord cyclooxygenase in human pain states than predicted by studies in animals.
Project description:BACKGROUND:Nonsteroidal antiinflammatory drugs are useful alternatives to narcotics for analgesia. However, concerns remain regarding their safety. The authors evaluated ketorolac use and complications. We hypothesized that no association between ketorolac and morbidity exists in patients undergoing body contouring. METHODS:Truven MarketScan claims database was analyzed for patients undergoing breast and body contouring surgery. Patients selected received ketorolac and were enrolled a minimum of 90 days. The authors performed a multivariable logistic regression to calculate risk of morbidity, adjusting for clinical and sociodemographic factors. RESULTS:Among the 106,279 patients enrolled, 4924 (4.6 percent) received postoperative ketorolac. In multivariable regression analysis, ketorolac was not associated with hematoma (OR, 1.20; 95 percent CI, 0.99 to 1.46; p > 0.05). There was an increased rate of reoperation within 72 hours (OR, 1.22; 95 percent CI, 1.00 to 1.49; p < 0.05; number needed to harm, 262 patients). Ketorolac was associated with fewer readmissions (OR, 0.76; 95 percent CI, 0.62 to 0.93; p < 0.05; number needed to treat, 87 patients), with a reduction in the rate of pain as a readmission diagnosis (0.6 percent versus 4.3 percent; p = 0.021). Ketorolac was associated with seroma, but this association may not be causal (OR, 1.28; 95 percent CI, 1.05 to 1.57; p < 0.05; number needed to harm, 247 patients). Ketorolac provided an estimated savings of $157 per patient. CONCLUSIONS:The benefits of ketorolac likely outweigh the risks after surgery. Absolute differences in reoperation rates were low, and improved rates of hospital admission impact cost savings. The authors advocate postoperative ketorolac once the wound is hemostatic. CLINICAL QUESTION/LEVEL OF EVIDENCE:Therapeutic, III.
Project description:BACKGROUND:The purpose of this study was to evaluate the effect of OMS302 on intraoperative pupil diameter and early postoperative ocular pain when administered during intraocular lens replacement surgery. METHODS:Four hundred and six patients (406 study eyes; 202 in the OMS302 group and 204 in the placebo group) were entered into this randomized, double-masked, placebo-controlled, multicenter Phase III study, which was conducted at 15 centers in the USA and the Netherlands. The patients received OMS302 (60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine) or placebo in irrigation solution during intraocular lens replacement. No other changes in procedure were required. Coprimary endpoints were change in pupil diameter over time from surgical baseline to end of procedure and patient-reported ocular pain during the first 12 hours postoperatively. Secondary endpoints included additional measures of pupil diameter and postoperative pain. RESULTS:OMS302 was superior to placebo in maintaining intraoperative mydriasis, preventing miosis, and reducing postoperative pain. The weighted mean (standard error) difference (OMS302 - placebo) in change in the area under the curve from baseline for pupil diameter was 0.590 ([0.049]; 95% confidence interval 0.494 to 0.686; P<0.0001). For ocular pain scores, the weighted mean (standard error) difference was -4.580 ([1.192]; 95% confidence interval -6.917 to 2.244; P=0.0002). All secondary efficacy results favored OMS302. Specifically, analyses supporting prevention of miosis (patients with ?6 mm pupil diameter at completion of cortical clean-up and those with <6 mm diameter at any time during surgery) were significant for OMS302 (95.9% versus 77.0% and 9.2% versus 38.0%, respectively; P<0.0001 for each endpoint). OMS302 was well tolerated and not associated with any unexpected adverse events. CONCLUSION:OMS302 maintained mydriasis, prevented miosis, and reduced early postoperative pain when administered in irrigation solution during intraocular lens replacement, with a safety profile similar to that of placebo. OMS302 is preservative-free and bisulfite-free, and its administration does not require any modification to the surgical procedure.
Project description: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.
Project description:While the pharmacokinetics of morphine in children have been studied extensively, little is known about the pharmacodynamics of morphine in this population. Here, we quantified the concentration-effect relationship of morphine for postoperative pain in preverbal children between 0 and 3 years of age. For this, we applied item response theory modeling in the pharmacokinetic/pharmacodynamic analysis of COMFORT-Behavior (COMFORT-B) scale data from 2 previous clinical studies. In the model, we identified a sigmoid maximal efficacy model for the effect of morphine and found that in 26% of children, increasing morphine concentrations were not associated with lower pain scores (nonresponders to morphine up-titration). In responders to morphine up-titration, the COMFORT-B score slowly decreases with increasing morphine concentrations at morphine concentrations >20 ng/mL. In nonresponding children, no decrease in COMFORT-B score is expected. In general, lower baseline COMFORT-B scores (2.1 points on average) in younger children (postnatal age <10.3 days) were found. Based on the model, we conclude that the percentage of children at a desirable COMFORT-B score is maximized at a morphine concentration between 5 and 30 ng/mL for children aged <10 days, and between 5 and 40 ng/mL for children >10 days. These findings support a dosing regimen previously suggested by Krekels et al, which would put >95% of patients within this morphine target concentration range at steady state. Our modeling approach provides a promising platform for pharmacodynamic research of analgesics and sedatives in children.
Project description:According to the lack of adequate studies on comparing the analgesic effect and complications of ketorolac with morphine in long bone fractures, this study aimed to compare the efficacy of ketorolac with morphine in patients referring to the Emergency Department with long bones damage and fracture.In this clinical trial study, 88 patients with long bone fracture were selected randomly and divided into two groups. To scale the intensity of pain, visual analog scale (VAS) were used. Intravenous ketorolac and morphine with the loading dose of 10 mg and 5 mg, respectively was administered to a group, followed by 5 mg and 2.5 mg every 5-20 min, if necessary (VAS ≥4). The pain scores before injection and at 5 min, half an hour and 1-h after the injection were measured and recorded for all patients.The mean age of the ketorolac and morphine groups was 29.1 ± 12.5 and 33.2 ± 11.4, respectively. In the groups, there was 63.6% and 70.5% of male patients respectively. The mean ± SD of pain score before the injection was 7.59 ± 1 and 7.93 ± 1.09 (P = 0.13). One hour after the injection, the mean ± SD of pain in the both groups was 1.41 ± 0.9 and 1.61 ± 1.17 and the mean pain score has no significant difference in the two groups before the injection. Repeated measures ANOVA test also showed that the trend of changes in pain score had no significant difference in both groups (P = 0.08).According to the fewer side effects of ketorolac and effective pain release versus morphine, ketorolac could be suggested to use.
Project description:The aim of this retrospective study was to compare immediate postoperative pain scores and need for rescue analgesia in children who underwent pulpotomies and restorative treatment and those who underwent restorative treatment only, all under general anaesthesia.Ninety patients aged between 3 and 7 years who underwent full mouth dental rehabilitation under general anaesthesia were enrolled in the study and reviewed. The experimental group included patients who were treated with at least one pulpotomy, and the control group was treated with dental fillings only. The Wong-Baker FACES scale was used to evaluate self-reported pain and need for rescue analgesia. The data were analysed using the Kruskal-Wallis test, two sample t-tests, chi-square tests, and Pearson's correlation analysis.Ninety percent of the children experienced postoperative pain in varying degrees of severity. Immediate postoperative pain scores in experimental group were found to be significantly higher than in control group (x2 = 24.82, p < 0.01). In the experimental group, 48% of the children needed rescue analgesia, compared with only 13% of the children in the control group (x2 = 13.27, p < 0.05).Children who underwent pulpotomy treatment had higher postoperative pain scores and greater need for rescue analgesia than control group who underwent only dental fillings.