RecruitingPhase 4NCT05875571

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

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


Sponsor

Arkansas Children's Hospital Research Institute

Enrollment

18 participants

Start Date

Feb 5, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 13 YearsMax Age: 21 Years

Inclusion Criteria1

  • Patients requiring sedated IUD placement at Arkansas Children's Hospital

Exclusion Criteria3

  • Allergy to ketorolac or other NDSAID
  • Known history of renal impairment
  • History of GI bleeding of peptic ulcer disease

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Interventions

DRUGKetorolac

Patients will get IV ketorolac during IUD placement under sedation

DRUGPlacebo

Patients will get IV placebo during IUD placement under sedation


Locations(1)

Arkansas Childrens Hospital

Little Rock, Arkansas, United States

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NCT05875571


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