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Nonsteroidal Anti-Inflammatory Drug

Ketorolac for Pain During IUD Placement

Phase 4
Recruiting
Research Sponsored by Arkansas Children's Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Must not have
History of GI bleeding or peptic ulcer disease
Known history of renal impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial aims to investigate if giving ketorolac along with propofol during IUD placement in adolescents can improve comfort during the procedure and reduce pain afterwards. The study will compare patients who receive

Who is the study for?
This trial is for healthy females at Arkansas Children's Hospital who need sedation for IUD placement. It's not suitable for those with allergies to NSAIDs like ketorolac, a history of kidney issues, or past GI bleeding/ulcers.
What is being tested?
The study tests if ketorolac can reduce pain when given with propofol during and after IUD insertion in adolescents. Participants will either receive ketorolac or a placebo alongside propofol to compare comfort levels.
What are the potential side effects?
Ketorolac may cause side effects such as stomach pain, heartburn, nausea, headaches, drowsiness, and bruising. Rarely it could lead to serious issues like GI bleeding or kidney problems.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had stomach ulcers or bleeding in my digestive tract.
Select...
I have a history of kidney problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Comparison of Post procedural pain after IUD placement
Secondary study objectives
total propofol dose (mg/kg) given in each group

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: KetorolacActive Control1 Intervention
The group of patients will receive IV Ketorolac before placement of IUD under sedation.
Group II: PlaceboPlacebo Group1 Intervention
The group of patients will receive placebo before placement of IUD under sedation.

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Who is running the clinical trial?

Arkansas Children's Hospital Research InstituteLead Sponsor
138 Previous Clinical Trials
5,025,598 Total Patients Enrolled
~6 spots leftby May 2025
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