Intravenous Ketorolac Administration to Attenuate Post-procedural Pain Associated With Intrauterine Device Placement

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age13-21
SponsorArkansas Children's Hospital Research Institute

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Ketorolac

    Drug

    Patients will get IV ketorolac during IUD placement under sedation

  • Placebo

    Drug

    Patients will get IV placebo during IUD placement under sedation

Treatment groups

18 Participants
are divided into 2 treatment groups
Group A: KetorolacActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
24 hours

Secondary outcomes

1

number of propofol boluses required during sedation

Time frame
24 hours
2

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

Time frame
24 hours

Other outcomes

Sponsors and contacts

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