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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Arkansas Children's Hospital Research Institute
Study ID
NCT05875571
Phase
PHASE4
Status
Recruiting
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Conditions

  • Contraception
  • Healthy Female
  • IUD
  • IUD Insertion Complication

Eligibility Criteria

Sex
FEMALE
Age
13 Years - 21 Years
Healthy Volunteers
Accepted

Interventions

  • Ketorolac — DRUG
    Patients will get IV ketorolac during IUD placement under sedation
  • Placebo — DRUG
    Patients will get IV placebo during IUD placement under sedation

Study Details

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.

Key Dates

Start date
Feb 5, 2024
Status verified
Jul 2024
Primary completion
May 31, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
18 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Ketorolac
    The group of patients will receive IV Ketorolac before placement of IUD under sedation.
  • Placebo Comparator: Placebo
    The group of patients will receive placebo before placement of IUD under sedation.

Primary Outcome Measure

Comparison of Post procedural pain after IUD placement [ Time Frame: 24 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Arkansas Childrens HospitalLittle RockArkansas72202
Shahwar Yousuf
[email protected]
501-364-1341
Lee Crawley
[email protected]

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By research site
Arkansas Childrens Hospital· Little Rock, AR

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