Intravenous Ketorolac Administration to Attenuate Post-procedural Pain Associated With Intrauterine Device Placement: A Randomized, Double-Blind, Placebo-Controlled Trial
Arkansas Children's Hospital Research Institute
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.
Description
Background and Significance: IUDs are safe, effective, and reversible forms of contraception. They are available in two forms in the United States: non-hormonal (copper) and levonorgestrel hormonal devices. There are very few contraindications to placement and few associated side effects. Despite these facts, only 14% of women aged 15-44 currently use an IUD1. Data over recent years show an increase in IUD usage among younger women, and the American College of Obstetricians and Gynecologists (ACOG) support use in adolescent patients, many of which seek care from pediatric providers2. IUDs are…
Eligibility
- Age range
- 13–21 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: * Patients requiring sedated IUD placement at Arkansas Children's Hospital Exclusion Criteria: * Allergy to ketorolac or other NDSAID * Known history of renal impairment * History of GI bleeding of peptic ulcer disease
Interventions
- DrugKetorolac
Patients will get IV ketorolac during IUD placement under sedation
- DrugPlacebo
Patients will get IV placebo during IUD placement under sedation
Location
- Arkansas Childrens HospitalLittle Rock, Arkansas