Actively Recruiting

Phase 4
Age: 13Years - 21Years
FEMALE
Healthy Volunteers
ID05875571

Intravenous Ketorolac to Reduce Pain After Intrauterine Device Placement in Adolescents Under Sedation

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

18

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Intrauterine devices (IUDs) are a widely used form of long-acting reversible contraception, particularly among adolescents, but pain during insertion can be a barrier. Researchers are studying whether adding ketorolac, a nonsteroidal anti-inflammatory drug (NSAID), to propofol sedation can reduce pain and improve comfort during and after IUD placement in adolescent females. This trial is a randomized, double-blind, placebo-controlled study assessing this combination in a pediatric population. Participants will be assigned to receive either intravenous ketorolac or a placebo before undergoing IUD placement under sedation with propofol. The sedation protocol includes an initial IV dose followed by an infusion and additional doses as needed. IUD placement will be performed using one of two levonorgestrel hormonal devices. The study drug is given at least 30 minutes before sedation starts, and patients are randomly assigned to the ketorolac or placebo group with all staff blinded to group assignment. Study participants will be monitored for pain levels within 24 hours following the procedure, along with the amount of propofol used during sedation. Data on the number of propofol boluses and total doses will also be collected. The study involves sedation monitoring by pediatric critical care or emergency physicians and includes assessments of procedural comfort and safety. Participation duration includes the procedure and the 24-hour post-procedural observation period.

CONDITIONS

Brief 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 intrauterine device placement at Arkansas Children's Hospital
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single day procedure

Participants receive intravenous ketorolac or placebo during sedation for intrauterine device placement to reduce post-procedural pain.

1 visit (in-person)

Follow-up

Duration - 24 hours

Participants are monitored for post-procedural pain and sedation effects after intrauterine device placement.

1 follow-up contact

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

J

Jill Gassaway

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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Published Research Related To This Trial

Pain perception with cervical tenaculum placement during intrauterine device insertion: a randomised controlled trial.

Tashima Lambert, Tracy Truong, Beverly Gray

https://pubmed.ncbi.nlm.nih.gov/31666302

10% lidocaine spray for pain control during intrauterine device insertion: a randomised, double-blind, placebo-controlled trial.

Nalinee Panichyawat, Theethat Mongkornthong, Thanyarat Wongwananuruk...

https://pubmed.ncbi.nlm.nih.gov/32591417

Paracervical Block for Intrauterine Device Placement Among Nulliparous Women: A Randomized Controlled Trial.

Sheila K Mody, John Paul Farala, Berenice Jimenez...

https://pubmed.ncbi.nlm.nih.gov/30095776

Pain scores at the insertion of the 52 MG levonorgestrel-releasing intrauterine system among nulligravidas and parous women.

Isabella A Chaves, Thaís Baêta, Gabriella B Dolabella...

https://pubmed.ncbi.nlm.nih.gov/34096433