Oral Ketorolac for IUD Pain Reduction

Phase 2

Not yet recruiting

• Conditions: IUD Insertion Pain
• Interventions: Drug: Ketorolac; Drug: Placebo

• Registration Number: NCT06853327
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-24
• Study First Submitted QC: 2025-02-24
• Last Update Submitted: 2025-02-24
• Study First Posted: 2025-02-28
• Last Update Posted: 2025-02-28
• Study Start: 2025-04-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
K2 - Ketorolac 2-hour	Ketorolac	Receives Ketorolac 20mg PO at 2 hours prior and placebo at 1 hour prior to IUD
K2 - Ketorolac 2-hour	Placebo	Receives Ketorolac 20mg PO at 2 hours prior and placebo at 1 hour prior to IUD
K1 - Ketorolac 1-hour	Ketorolac	Receives placebo at 2 hours and Ketorolac 20mg PO at 1 hour prior to IUD
K1 - Ketorolac 1-hour	Placebo	Receives placebo at 2 hours and Ketorolac 20mg PO at 1 hour prior to IUD
K0 - Placebo control	Placebo	Receives placebo at 2 hours and at 1 hour prior to IUD

Primary Outcome Measures

Name	Time	Method
Difference in mean VAS pain scores between study arms at 7 timepoints during and after IUD insertion	All VAS pain scores will be measured during their IUD appointment. 5 timepoints will be measured during IUD insertion (~10 total minutes), 1 immediately after the procedure, 1 ten minutes afterwards	To compare the mean VAS pain scores between study arms (K2 vs K1 vs K0) at each timepoint during and after IUD insertion (pre-procedure, tenaculum placement, PCB injection, uterine sounding, IUD deployment, overall (measured immediately post-procedure), and 10 minutes post-procedure). To assess VAS scores, a 100mm ruler will be presented to the patient at the listed timepoints. The patient will adjust a slider on the ruler to correspond to their pain level, with 0mm representing no pain and 100mm representing worst possible pain. The VAS scores will be reported as means and compared via repeated measure ANOVA test yielding confidence intervals and p-values and to assess for significance.

Secondary Outcome Measures

Name	Time	Method
Difference in mean VAS pain scores between study arms at 7 timepoints during and after IUD insertion, controlling for parity	Parity is recorded during intake 1 week prior to IUD. VAS pain scores will be measured during their IUD appointment. 5 timepoints will be measured during IUD insertion (~10 total minutes), 1 immediately after the procedure, 1 ten minutes afterwards	To compare the mean VAS pain scores between study arms (K2 vs K1 vs K0) at each timepoint during and after IUD insertion (pre-procedure, tenaculum placement, PCB injection, uterine sounding, IUD deployment, overall (measured immediately post-procedure), and 10 minutes post-procedure) with respect to parity. To assess VAS scores, a 100mm ruler will be presented to the patient at the listed timepoints. The patient will adjust a slider on the ruler to correspond to their pain level, with 0mm representing no pain and 100mm representing worst possible pain. This will determine if nulliparous patients experienced more pain relief with different timings of ketorolac administration. The VAS scores for nulliparous and multiparous patients will be reported as means and compared via repeated measure ANOVA test with interaction term yielding confidence intervals and p-values to assess for significance.
Difference in rate of "severe pain" (VAS pain scores 70-100mm) between study arms at 7 timepoints during and after IUD insertion	All VAS pain scores will be measured during their IUD appointment. 5 timepoints will be measured during IUD insertion (~10 total minutes), 1 immediately after the procedure, 1 ten minutes afterwards	To compare the rate of "severe pain" (VAS pain scores 70-100mm) between study arms (K2 vs K1 vs K0) at each timepoint during and after IUD insertion (pre-procedure, tenaculum placement, PCB injection, uterine sounding, IUD deployment, overall (measured immediately post-procedure), and 10 minutes post-procedure). To assess VAS scores, a 100mm ruler will be presented to the patient at the listed timepoints. The patient will adjust a slider on the ruler to correspond to their pain level, with 0mm representing no pain and 100mm representing worst possible pain. The rate of severe pain will be reported as percentage of patients and will be compared via chi-square test yielding confidence intervals and p-values to assess for significance.
Difference in rate of change of VAS pain scores between study arms at 7 timepoints during and after IUD insertion	All VAS pain scores will be measured during their IUD appointment. 5 timepoints will be measured during IUD insertion (~10 total minutes), 1 immediately after the procedure, 1 ten minutes afterwards	To compare the rate of change of VAS pain scores between study arms (K2 vs K1 vs K0) at each timepoint during and after IUD insertion (pre-procedure, tenaculum placement, PCB injection, uterine sounding, IUD deployment, overall (measured immediately post-procedure), and 10 minutes post-procedure). To assess VAS scores, a 100mm ruler will be presented to the patient at the listed timepoints. The patient will adjust a slider on the ruler to correspond to their pain level, with 0mm representing no pain and 100mm representing worst possible pain. The pain scores will be plotted at the listed 7 timepoints and a generalized estimating equation will be used to assess the change in slope from timepoint to timepoint. The change in slope will be reported as means and compared between study arms via repeated measure ANOVA test yielding confidence intervals and p-values and to assess for significance.
Difference in rate of acceptable pain levels between study arms at 7 timepoints during and after IUD insertion	All PASS responses will be measured during their IUD appointment. 5 timepoints will be measured during IUD insertion (~10 total minutes), 1 immediately after the procedure, 1 ten minutes afterwards	To compare the rate of acceptable pain levels (Patient Acceptable Symptom State (PASS) binary yes/no variable) between study arms (K2 vs K1 vs K0) at each timepoint during and after IUD insertion (pre-procedure, tenaculum placement, PCB injection, uterine sounding, IUD deployment, overall (measured immediately post-procedure), and 10 minutes post-procedure). To assess PASS, the patient will be asked "Do you consider your current pain level acceptable?" at the listed timepoints. The rate of acceptable pain levels will be reported as percentage of patients and will be compared via chi-square test yielding confidence intervals and p-values to assess for significance.

Trial Locations

Locations (1)

University of North Carolina - Hillsborough Campus; 🇺🇸 Hillsborough, North Carolina, United States