Oral Ketorolac for IUD Pain Reduction

University of North Carolina (UNC)

Status and phase: Invitation-only; Phase 2

Conditions: IUD Insertion Pain

Treatments: Drug: Ketorolac; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06853327

24-2276

Details and patient eligibility

About

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

Full description

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.

Enrollment: 108 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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108 participants in 3 patient groups, including a placebo group

K2 - Ketorolac 2-hour

Active Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Ketorolac

K1 - Ketorolac 1-hour

Active Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Ketorolac

K0 - Placebo control

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo