The safety of intrauterine devices among young women: a systematic review.
Tara C Jatlaoui, Halley E M Riley, Kathryn M Curtis
https://pubmed.ncbi.nlm.nih.gov/27771475Actively Recruiting
Led by Arkansas Children's Hospital Research Institute · Updated on 2024-07-31
18
Participants Needed
1
Research Sites
4 weeks
Total Duration
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
Intravenous Ketorolac Administration to Attenuate Post-procedural Pain Associated With Intrauterine Device Placement
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
Duration - 24 hours
Participants are monitored for post-procedural pain and sedation effects after intrauterine device placement.
1 follow-up contact
Total: 1 location
1
Arkansas Childrens Hospital
Little Rock, Arkansas, United States, 72202
Actively Recruiting
S
Shahwar Yousuf, MD
J
Jill Gassaway
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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