Oral Ketorolac for IUD Pain Reduction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE2

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-23

Study Completion Date

2026-06-30

Brief Summary

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To determine if oral ketorolac given at different timepoints prior to intrauterine device (IUD) insertion influences pain experienced during this procedure.

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Detailed Description

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This is a single-site prospective interventional randomized controlled trial to examine the timing of administration of ketorolac for IUD pain control. 108 patients will be recruited to the study and they will be randomized into three study arms in a 1:1:1 ratio. Information including demographics, medical history, and obstetric history will be collected during enrollment. Patients will arrive 3 hours prior to their IUD appointment. Study group "K2" will receive ketorolac 20mg per os (PO) at 2 hours prior to IUD insertion, then they will receive a placebo pill at 1 hour prior to IUD insertion. In contrast, study group "K1" will receive the inverse: they will be given a placebo pill at 2 hours prior to IUD insertion, then they will receive ketorolac 20mg PO at 1 hour prior to IUD insertion. Study group "K0" will receive placebo pills at both timepoints. The patients will then receive a standard IUD insertion by an OBGYN physician. Both patients and providers will be blinded to the study medications received. The standard pain control regimen for IUD insertion includes offering vaginal lidocaine gel self-administered 5 minutes prior to IUD insertion as well as offering lidocaine paracervical block (PCB). All patients will be offered these standard pain control methods including the "K0" group. Patients may utilize one, both, or neither of these offered interventions in addition to the randomized study medication. During the IUD insertion, pain scores at 7 different timepoints will be measured via a visual analog scale (VAS). The VAS is a 100mm visual tool that allows patients to rate the pain they are experiencing at each time interval. The 7 timepoints include: pre-procedure, tenaculum placement, block injection, uterine sounding, IUD deployment, overall (measured immediately post-procedure), and 10 minutes post-procedure. Information on Patient Acceptable Symptom State (PASS) and patient satisfaction will be collected during their appointment. After the 10-minute post-procedure VAS score and questionnaire, patients will be discharged from the study.

Conditions

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IUD Insertion Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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K2 - Ketorolac 2-hour

Receives Ketorolac 20mg PO at 2 hours prior and placebo at 1 hour prior to IUD

Group Type ACTIVE_COMPARATOR

Ketorolac

Intervention Type DRUG

The experimental condition to be examined by this study is the timing of administration of ketorolac prior to IUD insertion. Ketorolac 20mg PO has proven beneficial at certain timepoints during IUD insertion in prior studies, but pharmacokinetics indicate that it could require more time until peak analgesia.

Placebo

Intervention Type DRUG

Placebo will be used to control the timing of administration and be used to compare ketorolac to baseline standard pain control regimens

K1 - Ketorolac 1-hour

Receives placebo at 2 hours and Ketorolac 20mg PO at 1 hour prior to IUD

Group Type ACTIVE_COMPARATOR

Ketorolac

Intervention Type DRUG

The experimental condition to be examined by this study is the timing of administration of ketorolac prior to IUD insertion. Ketorolac 20mg PO has proven beneficial at certain timepoints during IUD insertion in prior studies, but pharmacokinetics indicate that it could require more time until peak analgesia.

Placebo

Intervention Type DRUG

Placebo will be used to control the timing of administration and be used to compare ketorolac to baseline standard pain control regimens

K0 - Placebo control

Receives placebo at 2 hours and at 1 hour prior to IUD

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be used to control the timing of administration and be used to compare ketorolac to baseline standard pain control regimens

Interventions

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Ketorolac

The experimental condition to be examined by this study is the timing of administration of ketorolac prior to IUD insertion. Ketorolac 20mg PO has proven beneficial at certain timepoints during IUD insertion in prior studies, but pharmacokinetics indicate that it could require more time until peak analgesia.

Intervention Type DRUG

Placebo

Placebo will be used to control the timing of administration and be used to compare ketorolac to baseline standard pain control regimens

Intervention Type DRUG

Other Intervention Names

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Toradol

Eligibility Criteria

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Inclusion Criteria

* 18 years or older
* Able to consent
* Desires IUD insertion

Exclusion Criteria

* IUD placement under sedation or oral anxiolytic
* IUD replacement (removal with insertion)
* Daily narcotic or NSAID use
* Contraindications to IUD placement
* Current: pregnancy, genital/pelvic infection
* Lifetime history: uterine anomaly, pelvic inflammatory disease, allergy to levonorgestrel or copper
* Contraindications to ketorolac
* Current: weight under 50 kilograms
* Lifetime history: allergy to NSAIDs, liver disease, renal disease, peptic ulcer disease, cerebrovascular bleeding, gastrointestinal bleeding

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes