drugset / Trial / NCT03467750

Effect of Ketorolac on Post Adenotonsillectomy Pain

NCT03467750

Phase 4 Completed 63 enrolled Emory University
RandomizedParallel-groupSingle-blindSupportive care

Summary

This randomized prospective study aims to determine the effect of ketorolac on the total dose of morphine required to achieve postoperative analgesia in children with obstructive sleep apnea (OSA) undergoing adenotonsillectomy. Participants will be randomly assigned to a study group where they will receive ketorolac in addition to the standard of care treatment or will receive only the standard of care pain management. The researchers hypothesize that by administering ketorolac at the end of the procedure once hemostasis has been achieved, it will be possible to decrease the amount of morphine administered in the post-anesthesia care unit (PACU). This study aims to provide a more comprehensive understanding of the efficacy and safety of the current standard post-operative analgesic regimen employed at the study institution, in which opioid analgesia currently plays a prominent role.

Timeline

Start
2018-07-19
Primary completion
2023-08-22
Completion
2023-08-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketorolac Other / unclassified 0.5 mg/kg Intravenous
Background Acetaminophen Small molecule 15 mg/kg Intravenous
Background Dexamethasone Small molecule 0.5 mg/kg
Background Dexmedetomidine Other / unclassified 0.5 ug/kg
Background Fentanyl Other / unclassified 0.5 ug/kg Intravenous
Background Fentanyl Other / unclassified 1 ug/kg Intravenous
Background Morphine Other / unclassified 0.025 mg/kg
Background Morphine Other / unclassified 0.05 mg/kg
Background Nitrous Oxide Other / unclassified Inhaled
Background Ondansetron Other / unclassified 0.1 mg/kg
Background Propofol Small molecule 1 mg/kg Intravenous
Background Propofol Small molecule 3 mg/kg Intravenous
Background Sevoflurane Other / unclassified Inhaled