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SKOPE-Study of Ketorolac vs Opioid for Pain after Endoscopy: A Double-Blinded Randomized Control Trial in Patients Undergoing Ureteroscopy.
Fedrigon, D, Faris, A, Kachroo, N, Jain, R, Elia, M, Wilkins, L, Li, J, De, S, Noble, M, Monga, M, et al
The Journal of urology. 2021;(2):373-381
Abstract
PURPOSE Pain is the leading cause of unplanned emergency department visits and readmissions after ureteroscopy, making postoperative analgesic stewardship a priority given the current opioid epidemic. We conducted a double-blinded, randomized controlled trial, with noninferiority design, comparing nonsteroidal anti-inflammatory drugs to opiates for postoperative pain control in patients undergoing ureteroscopy for urolithiasis. MATERIALS AND METHODS Patients were randomized and blinded to either oxycodone (5 mg) or ketorolac (10 mg), taken as needed, with 3 nonblinded oxycodone rescue pills for breakthrough pain. Primary study outcome was visual analogue scale pain score on postoperative days 1-5. Secondary outcomes included medication utilization, side effects, and Ureteral Stent Symptom Questionnaire scores. RESULTS A total of 81 patients were included (43 oxycodone, 38 ketorolac). The 2 groups had comparable patient, stone, and perioperative characteristics. No differences were found in postoperative pain scores, study medication or rescue pill usage, or side effects. Higher maximum pain scores on days 1-5 (p <0.05) and higher questionnaire score (28.1 vs 21.7, p=0.045) correlated with analgesic usage, irrespective of treatment group. Patients receiving ketorolac reported significantly fewer days confined to bed (mean±SD 1.3±1.3 vs 2.3±2.6, p=0.02). There was no difference in unscheduled postoperative physician encounters. CONCLUSIONS This is the first double-blinded randomized controlled trial comparing nonsteroidal anti-inflammatory drugs and opiates post-ureteroscopy, and demonstrates noninferiority of nonsteroidal anti-inflammatory drugs in pain control with similar efficacy, safety profile, physician contact and notably, earlier convalescence compared to the opioid group. This provides strong evidence against routine opioid use post-ureteroscopy, justifying continued investigation into reducing postoperative opiate prescriptions.
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Randomised trial of IV metoclopramide vs IV ketorolac in treatment of acute primary headaches.
Soltani, KM, Motamed, H, Eslami, K, Majdinasab, N, Kouti, L
The American journal of emergency medicine. 2021;:376-380
Abstract
INTRODUCTION Headache is one of the most common neurological conditions among emergency department visits (ED), although the best therapy has not been identified yet. Therefore, in the current study, we aimed to compare the pain-relieving effect of metoclopramide and ketorolac in acute primary headaches patients. METHODS This double-blind, randomised clinical trial was conducted at Golestan Hospital, Ahvaz, Iran. This research involved all adult patients with acute primary (migraine or tension-type) headaches presented to the ED. Pain intensity was assessed with 0 to 10 verbal Numeric Rating Scales (NRS). The subjects were randomised into 10 mg intravenous (IV) metoclopramide or 30 mg IV ketorolac groups. Pain score and drug adverse reactions were compared between the two groups at baseline, 15, 30, and 60 min after baseline. RESULTS 108 patients completed this trial and were equally divided into two groups (mean age of 34 ± 8.54 years; 57.4% female). Before treatment, the mean pain score was 6.9 and 6.8 in metoclopramide and ketorolac groups, respectively (p > 0.05). Metoclopramide failed to provide more improvement in pain score at 30 min (p = 0.55) and 60 min (p = 0.15) from baseline. There were no serious adverse events in this study. Only five patients required rescue medication which four of them were in ketorolac group. CONCLUSION We were unable to reject the null hypothesis that there would be no difference in pain outcomes between metoclopramide and ketorolac.
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Comparison of efficacy nebulized fentanyl with intravenous ketorolac for renal colic in patients over 12 years old.
Rezaei, B, Salimi, R, Kalantari, A, Astaraki, P
The American journal of emergency medicine. 2021;:358-361
Abstract
OBJECTIVES Acute renal colic is one of the common causes of referral to the hospitals. The aim of this study is to compare the efficacy of nebulized fentanyl with that of intravenous ketorolac in renal colic patients. MATERIALS & METHODS This double-blinded clinical study included 186 patients with acute renal colic who were referred to the emergency department of Besat Hospital, Iran. PATIENT SELECTION After selecting patients, according to study inclusion and exclusion criteria, they were divided into 2 groups of 93 using random block allocation method. The patients in the groups were treated with either nebulized fentanyl or intravenous ketorolac. The severity of pain was measured using the Numeric Pain Rating Scale (NPRS) of pain. The severity of pain at different times and demographic data were recorded. RESULTS One hundred and thirty four males and 52 females with a mean age of 42.95 ± 13.13 years were included in the study. The two groups were matched in terms of age, sex, and the severity of the pain before the treatment. Fifteen minutes following the treatment, the severity of pain was decreased in the ketorolac group but did not change in the nebulized fentanyl group. Thirty minutes after the administration of the drug, the severity of pain in the nebulized fentanyl group decreased. At any time, the severity of pain in the ketorolac group was lower than that of the nebulized fentanyl group. CONCLUSION Intravenous ketorolac had better analgesic effects in renal colic patients compared with nebulized fentanyl. Further studies that include complications and combinational therapy are required.
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4.
Development of Composition and Technologies of Dental Film with Ketorolac Trometamine.
Bakhrushina, EO, Demina, NB, Kashperko, AS, Vakina, MG, Anurova, MN, Zhilyakova, ET, Krasnyuk, II
Drug research. 2021;(2):104-107
Abstract
The report presents the results of the development of dental films with ketorolac trometamine based on the natural biodegradable polymers from the groups of sodium alginates and xanthan gums in combination with lightly crosslinked acrylic polymer carbopol. Physicochemical properties, such as moisture, mucoadhesion, thickness, tensile strength, disintegration in phosphate buffer were determined in obtained samples of this dosage form. A comparison of physicochemical properties of experimental samples and commercial model of dental film has allowed establishing the perspective composition of complex matrix of films with ketorolac trometamine for use in dentistry.
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Intranasal ketorolac, diagnosis, and desensitization for aspirin-exacerbated respiratory disease.
Nguyen, A, Zuraw, BL, Wu, C, Kim, A, Christiansen, SC
Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology. 2021;(6):674-680
Abstract
BACKGROUND Intranasal ketorolac has been proposed as a diagnostic test for aspirin-exacerbated respiratory disease (AERD) and a faster, safer, and reliable addition to facilitating aspirin (ASA) desensitization. OBJECTIVE We conducted the first prospective study to dissect the impact of intranasal ketorolac incorporation during ASA desensitization vs standard oral protocols in concert with evaluating its diagnostic use for AERD. METHODS Patients with AERD were enrolled in a prospective open-label observational study between November 2006 and August 2013. Participants selected either one of the following desensitization protocols: intranasal ketorolac 1 day before oral ASA (group 1, combined) or ketorolac challenge with greater than 2 weeks elapsing until oral ASA (group 2, washout). All patients were on a leukotriene-modifying drug (montelukast) for at least 1 week before the challenge. RESULTS A total of 20 patients were enrolled: 13 in group 1 and 7 in group 2. No significant differences were seen for baseline symptom scores or forced expiratory volume in 1 second. Group 1 exhibited significant increases for the threshold dose of ASA (P = .009), the likelihood of having silent ASA desensitization (P = .01), and decreased reaction severity to oral ASA (P = .04). There were no significant differences in reaction forced expiratory volume in 1 second, the incidence of extrapulmonary symptoms, limited nasoocular reactions, rescue treatment requirements, or time to symptom resolution. There was 100% concordance between reactions to intranasal ketorolac and oral ASA for group 2, supporting its use as a diagnostic test for AERD. CONCLUSION Intranasal ketorolac is a useful diagnostic test and adjunct within the combined ketorolac/ASA protocol to achieve effective, efficient, and perhaps safer desensitization to ASA for patients with AERD.
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The Effect of Perioperative Ketorolac Administration on Opioid Use After Hip Arthroscopy.
Cunningham, D, Lewis, B
Orthopedics. 2021;(3):e417-e421
Abstract
Patients undergoing hip arthroscopy often have postoperative pain that is managed in part with opioids. The hypothesis of this study was that administration of ketorolac at the conclusion of the case may improve postoperative pain control and reduce opioid use. This investigation was a retrospective, observational study of opioid use, pain, and time spent in the postanesthesia care unit (PACU) among opioid-naïve patients undergoing primary hip arthroscopy (Current Procedural Terminology code 29914 or 29916) for femoroacetabular impingement syndrome before and after the institution of a surgeon-driven policy to administer ketorolac at the end of the case. Baseline characteristics and perioperative ketorolac administration were recorded. Outcomes included opioids used in the PACU through discharge measured in oral morphine equivalents, time spent in the PACU, and pain reported by the patient in the PACU. Comparative statistics, including multivariable main effects linear regression modeling, were performed to determine the effect of ketorolac administration on outcomes. Patients who did not receive ketorolac consumed a median of 22.5 oral morphine equivalents in the PACU through discharge, whereas patients who received ketorolac consumed a median of 17.5 oral morphine equivalents. No significant difference was found in pain reported or time spent in the PACU through discharge, although the results favored ketorolac administration. This study showed a modest but statistically significant reduction in early postoperative opioid use among patients receiving ketorolac at closure. Ketorolac could be part of a multimodal preemptive pain management strategy to help to reduce postoperative opioid use. [Orthopedics. 2021;44(3):e417-e421.].
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Investigation of sumatriptan and ketorolac trometamol in the human experimental model of headache.
Ghanizada, H, Al-Karagholi, MA, Arngrim, N, Mørch-Rasmussen, M, Metcalf-Clausen, M, Larsson, HBW, Amin, FM, Ashina, M
The journal of headache and pain. 2020;(1):19
Abstract
BACKGROUND Pituitary adenylate cyclase-activating polypeptide-38 (PACAP38) induces headache in healthy volunteers but the precise mechanisms by which PACAP38 leads to headache are unclear. We investigated the headache preventive effect of sumatriptan and ketorolac on PACAP38-induced headache in healthy volunteers. In addition, we explored contribution of vascular mechanisms to PACAP38-induced headache using high resolution magnetic resonance angiography. METHODS Thirty-four healthy volunteers were divided in two groups (A and B) and received infusion of PACAP38 (10 picomol/kg/min) over 20 min. Group A was pretreated with intravenous sumatriptan (4 mg) or ketorolac (30 mg) 20 min before infusion of PACAP38. Group B received infusion of sumatriptan or ketorolac as post-treatment 90 min after infusion of PACAP38. In both experiments, we used a randomized, double-blind, cross-over design. We recorded headache characteristics and circumference of extra-intracerebral arteries. RESULTS We found no difference in AUC (0-6 h) of PACAP38-induced headache in group A, pretreated with sumatriptan or ketorolac (p = 0.297). There was no difference between sumatriptan and ketorolac in PACAP38-induced circumference change (AUCBaseline-110 min) of MMA (p = 0.227), STA (p = 0.795) and MCA (p = 0.356). In group B, post-treatment with ketorolac reduced PACAP38-headache compared to sumatriptan (p < 0.001). Post-treatment with sumatriptan significantly reduced the circumference of STA (p = 0.039) and MMA (p = 0.015) but not of MCA (p = 0.981) compared to ketorolac. In an explorative analysis, we found that pre-treatment with sumatriptan reduced PACAP38-induced headache compared to no treatment (AUC0-90min). CONCLUSIONS Post-treatment with ketorolac was more effective in attenuating PACAP38-induced headache compared to sumatriptan. Ketorolac exerted its effect without affecting PACAP38-induced arterial dilation, whereas sumatriptan post-treatment attenuated PACAP38-induced dilation of MMA and STA. Pre-treatment with sumatriptan attenuated PACAP38-induced headache without affecting PACAP38-induced arterial dilation. Our findings suggest that ketorolac and sumatriptan attenuated PACAP38-induced headache in healthy volunteers without vascular effects. TRIAL REGISTRATION Clinicaltrials.gov (NCT03585894). Registered 13 July 2018.
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Comparing the effects of ketorolac and Paracetamol on postoperative pain relief after coronary artery bypass graft surgery. A randomized clinical trial.
Javaherforooshzadeh, F, Abdalbeygi, H, Janatmakan, F, Gholizadeh, B
Journal of cardiothoracic surgery. 2020;(1):80
Abstract
INTRODUCTION Pain management after coronary artery bypass graft (CABG) surgery remains challenging. OBJECTIVE This study aimed to compare the effects of Ketorolac and Paracetamol on postoperative CABG pain relief. METHOD This double-blind randomized clinical trial study was conducted in Ahvaz, Iran, from September 2018-December 2019. Two consecutive groups of 60 patients undergoing elective on-pump coronary artery bypass graft surgery. INTERVENTION The patients were divided into 0.5 mg/kg of ketorolac mg/dl and 10 mg/kg of Paracetamol after surgery for pain management. Primary outcomes were: visual analog pain scale (VAS) at the time point immediately after extubation (baseline) and at 6, 12, 24 and 48 h and the total dose of morphine consumption. Secondary outcomes included the hemodynamic variables, weaning time, chest tube derange, in-hospital mortality and myocardial infarction. STATISTICAL ANALYSIS The data were analyzed using SPSS version 22(SPSS, Chicago, IL). The Mann-Whitney U-test was used to compare demographic data, VAS scores, vital signs, and side effects. Repeated measurements were tested within groups using Friedman's ANOVA and the Wilcoxon rank-sum test. Values were expressed as means ± standard deviations. Statistical significance was defined as a p-value < 0.05. RESULTS Compared with baseline scores, there were significant declines in VAS scores in both groups throughout the time sequence (P< 0.05). The statistical VAS score was slightly higher in the Paracetamol group at most time points, except for the time of 6 h. However, at 24 and 48 h, the VAS score in group Paracetamol was significantly higher than in group Ketorolac. There were no significant differences between groups about hemodynamic variables. CONCLUSION The efficacy of ketorolac is comparable to that of Paracetamol in postoperative CABG pain relief. TRIAL REGISTRY IRCT20150216021098N5. Registered at 2019-09-12.
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Comparing Ketorolac With Ibuprofen for Postoperative Pain: A Randomized Clinical Trial.
Dwarica, DS, Pickett, SD, Zhao, YD, Nihira, MA, Quiroz, LH
Female pelvic medicine & reconstructive surgery. 2020;(4):233-238
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Abstract
OBJECTIVES The objective of this study was to identify differences in pain perception and satisfaction with pain control in women receiving nonsteroidal anti-inflammatory drugs postoperatively. METHODS This 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. RESULTS A 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. CONCLUSIONS There 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.
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Atomized intranasal vs intravenous fentanyl in severe renal colic pain management: A randomized single-blinded clinical trial.
Nazemian, N, Torabi, M, Mirzaee, M
The American journal of emergency medicine. 2020;(8):1635-1640
Abstract
OBJECTIVES Renal colic is one of the most common painful disorders in patients referred to the emergency department. The main purpose of this study was to compare the efficiency of two methods of intravenous (IVF) and intranasal (INF) fentanyl administration in pain management in patients with severe renal colic. MATERIALS & METHODS This was a single-blind randomized clinical trial performed on patients with severe renal colic. The severity of pain was ≥8 based on the Numerical Rating Scale (NRS). The efficacy of pain management was compared within and between the IVF (intramuscular Ketorolac + intravenous fentanyl) and INF (intramuscular Ketorolac + intranasal fentanyl) groups at different times points. Oral consent was obtained from all the patients. RESULTS Of 220 individuals, 96 (43.60%) were women and 124 (56.40%) were men. There were no significant differences between the two groups regarding the baseline pain severity, age, sex, history of urolithiasis and body mass index (BMI). The pain severity showed a significant reducing trend in both groups (p < 0.0001). There was also a significant difference comparing the mean pain severity between groups at different times (p < 0.0001). In each group, the severity of pain showed significant reduction compared with its prior measurement (P < 0.0001). CONCLUSION Fentanyl is highly effective in controlling pain in patients with severe renal colic referring to the emergency department. Intranasal administration of fentanyl combination with ketorolac can be an appropriate, non-invasive, easy-to-use and fast alternative to the intravenous method to manage pain in these patients.