Actively Recruiting

Phase 4
Age: 13Years - 21Years
FEMALE
Healthy Volunteers
NCT05875571

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

Led by Arkansas Children's Hospital Research Institute · Updated on 2024-07-31

18

Participants Needed

1

Research Sites

68 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 13Years - 21Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients requiring sedated IUD placement at Arkansas Children's Hospital
Not Eligible

You will not qualify if you...

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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Arkansas Childrens Hospital

Little Rock, Arkansas, United States, 72202

Actively Recruiting

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Research Team

S

Shahwar Yousuf, MD

CONTACT

J

Jill Gassaway

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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