About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients requiring sedated IUD placement at Arkansas Children's Hospital
Disqualifiers
Allergy to ketorolac or other NDSAID
Known history of renal impairment
History of GI bleeding of peptic ulcer disease
Trial design
Parallel
Treatments tested in this trial
Ketorolac
DrugPatients will get IV ketorolac during IUD placement under sedation
Placebo
DrugPatients will get IV placebo during IUD placement under sedation
Treatment groups
Trial outcomes
Primary outcomes
Comparison of Post procedural pain after IUD placement
The primary outcome will be comparison of post-procedural pain using the Numerical Pain Rating Scale in ketorolac vs placebo group. The scale ranges from 0 to10 where 0 = no pain at all and 10= worst pain ever. Lower score indicates improvement in pain while a higher score indicates worsening of pain.
Secondary outcomes
number of propofol boluses required during sedation
total propofol dose (mg/kg) given in each group
total propofol dose will be obtained from EHR and both groups will be compared for this purpose
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