Oral Ketorolac for IUD Pain Reduction

NCT06853327 | Enrolling By Invitation Phase 2 FDA Drug

• 1 other identifier: 24-2276
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

IUD Insertion Pain

Keywords

IUD; Intrauterine Device; Ketorolac; IUD pain; NSAID; Non-steroidal Anti-Inflammatory Drug; VAS; PASS

Outcome Measures

Primary Outcomes (1)

• Difference in mean VAS pain scores between study arms at 7 timepoints during and after IUD insertion

  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.

  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

Secondary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (3)

K2 - Ketorolac 2-hour

ACTIVE COMPARATOR

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

Drug: Ketorolac; Drug: Placebo

K1 - Ketorolac 1-hour

ACTIVE COMPARATOR

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

Drug: Ketorolac; Drug: Placebo

K0 - Placebo control

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Ketorolac 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.

Also known as: Toradol

K1 - Ketorolac 1-hour; K2 - Ketorolac 2-hour

Placebo 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; K1 - Ketorolac 1-hour; K2 - Ketorolac 2-hour

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Able to consent
• Desires IUD insertion

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina - Hillsborough Campus

Hillsborough, North Carolina, 27278, United States

Location

Related Publications (8)

• Crawford M, Davy S, Book N, Elliott JO, Arora A. Oral Ketorolac for Pain Relief During Intrauterine Device Insertion: A Double-Blinded Randomized Controlled Trial. J Obstet Gynaecol Can. 2017 Dec;39(12):1143-1149. doi: 10.1016/j.jogc.2017.05.014. Epub 2017 Aug 18.

  PMID: 28826645 BACKGROUND

• Ngo LL, Ward KK, Mody SK. Ketorolac for Pain Control With Intrauterine Device Placement: A Randomized Controlled Trial. Obstet Gynecol. 2015 Jul;126(1):29-36. doi: 10.1097/AOG.0000000000000912.

  PMID: 26241253 BACKGROUND

• de Oliveira ECF, Baeta T, Brant APC, Silva-Filho A, Rocha ALL. Use of naproxen versus intracervical block for pain control during the 52-mg levonorgestrel-releasing intrauterine system insertion in young women: a multivariate analysis of a randomized controlled trial. BMC Womens Health. 2021 Oct 29;21(1):377. doi: 10.1186/s12905-021-01521-z.

  PMID: 34715839 BACKGROUND

• Ngo LL, Braaten KP, Eichen E, Fortin J, Maurer R, Goldberg AB. Naproxen Sodium for Pain Control With Intrauterine Device Insertion: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1306-1313. doi: 10.1097/AOG.0000000000001746.

  PMID: 27824753 BACKGROUND

• Bednarek PH, Creinin MD, Reeves MF, Cwiak C, Espey E, Jensen JT; Post-Aspiration IUD Randomization (PAIR) Study Trial Group. Prophylactic ibuprofen does not improve pain with IUD insertion: a randomized trial. Contraception. 2015 Mar;91(3):193-7. doi: 10.1016/j.contraception.2014.11.012. Epub 2014 Nov 25.

  PMID: 25487172 BACKGROUND

• Reeves JA, Zapata LB, Curtis KM, Whiteman MK. Intrauterine Device Training, Attitudes, and Practices Among U.S. Health Care Providers: Findings from a Nationwide Survey. Womens Health Issues. 2023 Jan-Feb;33(1):45-53. doi: 10.1016/j.whi.2022.08.002. Epub 2022 Sep 16.

  PMID: 36123229 BACKGROUND

• Akintomide H, Brima N, Sewell RD, Stephenson JM. Patients' experiences and providers' observations on pain during intrauterine device insertion. Eur J Contracept Reprod Health Care. 2015;20(4):319-26. doi: 10.3109/13625187.2015.1031885. Epub 2015 Apr 10.

  PMID: 25857221 BACKGROUND

• Rahman M, King C, Saikaly R, Sosa M, Sibaja K, Tran B, Tran S, Morello P, Yeon Seo S, Yeon Seo Y, Jacobs RJ. Differing Approaches to Pain Management for Intrauterine Device Insertion and Maintenance: A Scoping Review. Cureus. 2024 Mar 8;16(3):e55785. doi: 10.7759/cureus.55785. eCollection 2024 Mar.

  PMID: 38586685 BACKGROUND

MeSH Terms

Interventions

Ketorolac; Ketorolac Tromethamine

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Amy G Bryant, M.D.

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 28, 2025
• Study Start: May 23, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: beginning 9 and continuing for 36 months after publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)