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Nonsteroidal Anti-Inflammatory Drug

Ketorolac for Intrauterine Device

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Comparison of Post procedural pain after IUD placement
Secondary outcome measures
number of propofol boluses required during sedation
total propofol dose (mg/kg) given in each group

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.

Find a Location

Who is running the clinical trial?

Arkansas Children's Hospital Research InstituteLead Sponsor
135 Previous Clinical Trials
5,029,347 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential participants currently able to apply for enrollment in this ongoing clinical trial?

"Yes, the details on clinicaltrials.gov reveal that this investigation is actively seeking volunteers. The trial was first listed on February 5th, 2024 and most recently revised on February 1st, 2024. Recruitment aims to enroll 18 participants from a single site."

Answered by AI

Who is eligible to participate in this particular medical study?

"Candidates aged between 13 and 21 years old who currently have an intrauterine device are sought to participate in this research. Approximately 18 individuals meeting these criteria will be enrolled."

Answered by AI

Are individuals aged 65 and above eligible to participate in this study?

"Recruitment for this research study is limited to individuals aged over 13 years but under 21 years."

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What is the safety profile of Ketorolac for individuals?

"Rated as a 3 on the safety scale, our team at Power deems Ketorolac safe due to its Phase 4 status signifying approval for use."

Answered by AI
~12 spots leftby Apr 2025