Introduction: Experimental data suggest that nonsteroidal antiinflammatory drugs may prevent disease severity and mortality in acute pancreatitis (AP). The aim of this study was to compare the efficacy of rectal indomethacin vs placebo in reducing the systemic inflammatory response syndrome (SIRS) score in a high-risk AP population for clinical progression.
Methods: We conducted a single-center, quadruple-blinded, randomized, placebo-controlled trial. Eligible criteria were subjects with AP and SIRS within 72 hours of presentation and those without organ failure. Subjects were allocated in a 1:1 ratio to indomethacin or placebo using simple randomization. Both interventions were administered rectally every 8 hours for 6 doses and compared using both intention-to-treat and per-protocol analyses.
Results: A total of 42 subjects (mean age 52 years, 55% men) were randomized to indomethacin (n = 18) or placebo (n = 24). There was no significant difference between the indomethacin and placebo groups in the change of SIRS score, proportion of subjects with SIRS, and distribution of SIRS scores at 24, 48, and 72 hours from randomization. There were no significant differences in the change of C-reactive protein levels at 48 hours or clinical outcomes between both treatment groups. Indomethacin was as safe as placebo, with 2 adverse events occurring in the placebo and none in the indomethacin arm.
Discussion: Rectal indomethacin can be safely administered over 48 hours; however, it is not superior to placebo in reducing the SIRS or clinical progression in a high-risk population with AP (ClinicalTrials.gov: NCT02692391).
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http://dx.doi.org/10.14309/ctg.0000000000000415 | DOI Listing |
Iran J Med Sci
November 2024
Anesthesiology and Critical Care Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.
Background: Acute renal colic has been challenging and has brought many concerns for physicians and patients for centuries. This study aimed to evaluate the analgesic effect and safety of a combination of papaverine and ketorolac against ketorolac and placebo in treating acute renal colic.
Methods: This randomized clinical trial was performed in patients with renal colic from May 2018 to May 2020 in Ahvaz, Iran.
Pharmacol Res Perspect
December 2024
Health Sciences Center, Stomatology Department, Autonomous University of Aguascalientes, Aguascalientes, Mexico.
The primary objective of the present review was to report the safety profile of oral ketorolac in adults using the systematic review and meta-analysis methodology based on clinical trials. The present study is a PRISMA-based systematic review and risk ratio (RR) meta-analysis of the adverse events reported in clinical trials that used oral ketorolac; the review includes 50 clinical trials. The RR for the comparison of a single intake of oral ketorolac versus placebo, including all types of adverse events, was RR = 2.
View Article and Find Full Text PDFSyst Rev
November 2024
Honghui-Hospital, Xi'an Jiaotong University, Xi'an, 710054, China.
Background: Ketorolac is widely utilized for postoperative pain management, including back pain after lumbar spinal surgery. Several trials have assessed the efficacy of Ketorolac alone and in combination with other analgesics such as bupivacaine, morphine, epinephrine, paracetamol, and pregabalin. However, the effects and safety profile of ketorolac in these contexts remain controversial.
View Article and Find Full Text PDFMolecules
October 2024
Departamento de Química, Universidad Técnica Particular de Loja, San Cayetano Alto s/n, Loja 1101608, Ecuador.
Chronic disease inflammation requires safe complementary treatments. The pericarp of var. (PTM) contains potential anti-inflammatory metabolites.
View Article and Find Full Text PDFEur J Contracept Reprod Health Care
December 2024
Department of Obstetrics and Gynaecology, Faculty of Medical Sciences, University of Campinas, Campinas, SP, Brazil.
Objective: We assessed whether the administration of oral ketorolac with an analgesic provides effective pain relief during placement of an intrauterine device (IUD) in nulligravid women.
Methods: We conducted a double-blinded randomised trial in the Department of Obstetrics and Gynaecology, University of Campinas Faculty of Medical Sciences, Campinas, SP, Brazil. We randomised participants who voluntarily agreed to participate to receive either one pill containing ketorolac 20 mg together with one pill containing dipyrone 300 mg, scopolamine 6.
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