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RECRUITING
NCT05875571
PHASE4

Intravenous Ketorolac Administration to Attenuate Post-procedural Pain Associated With Intrauterine Device Placement

Sponsor: Arkansas Children's Hospital Research Institute

View on ClinicalTrials.gov

Summary

Intrauterine devices (IUDs) are a popular form of long-acting reversible contraception, with a high efficacy rate and few side effects. The insertion procedure for IUDs can be uncomfortable and painful. Sedation may be needed to improve patient comfort. The use of IUDs is increasing in the adolescent population, but perceived pain is a barrier to placement. Propofol is a commonly used agent for pediatric procedural sedation, but it has no analgesic properties. Ketorolac, a nonsteroidal anti-inflammatory drug, has been shown to reduce pain in adults and improve patient satisfaction when used prior to IUD placement.. The current study aims to determine if ketorolac, given in combination with propofol for IUD placement in adolescents, can improve comfort during placement and reduce pain following the procedure. Enrolled patients will receive ketorolac or placebo, in addition to propofol, for IUD placement. By comparing the outcomes of these two groups of patients, we can gain a better understanding of the optimal approach to sedation for IUD insertion in adolescents.

Official title: Intravenous Ketorolac Administration to Attenuate Post-procedural Pain Associated With Intrauterine Device Placement: A Randomized, Double-Blind, Placebo-Controlled Trial

Key Details

Gender

FEMALE

Age Range

13 Years - 21 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2024-02-05

Completion Date

2025-06

Last Updated

2024-07-31

Healthy Volunteers

Yes

Interventions

DRUG

Ketorolac

Patients will get IV ketorolac during IUD placement under sedation

DRUG

Placebo

Patients will get IV placebo during IUD placement under sedation

Locations (1)

Arkansas Childrens Hospital

Little Rock, Arkansas, United States