Oral Ketorolac for Pain Relief During IUD Insertion

NCT03031795 | Completed Phase 4 Results DMC

• 1 other identifier: OH1-13-00503
• Study Type: interventional
• Target: 71
• Locations: 0 countries
• Sites: N/A

Brief Summary

Ketorolac is a non-steroidal anti-inflammatory drug (NSAID), similar to ibuprofen but it is used to treat more severe pain. Ketorolac (Trade name: Toradol) is typically used after surgical procedures. When taken orally, it should not cause sedation. The purpose of this study is to determine if oral ketorolac is effective at reducing pain during IUD placement versus a placebo tablet.

Conditions

Contraception

Keywords

intrauterine device

Outcome Measures

Primary Outcomes (1)

• Pain Before, During and After IUD Placement

  Pain before, during and after IUD placement on a 0 (no pain) to 10 (worst possible) scale. Higher score mean a worse outcome.

  Before, during and after IUD placement

Study Arms (2)

experimental

EXPERIMENTAL

ketorolac, oral, 20 mg, 1 dose, 45 minutes prior to IUD placement

Drug: Ketorolac

placebo

PLACEBO COMPARATOR

look alike placebo

Drug: Placebo

Interventions

Ketorolac DRUG

Oral Tablet

Also known as: Toradol

experimental

Placebo DRUG

Oral Tablet

placebo

Eligibility Criteria

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

You may qualify if:

• non-pregnant
• English speaking women
• years of age or older desiring an IUD for contraception

You may not qualify if:

• enrollment in another study
• pre-medication with any type of analgesic medication
• contraindication to an IUD
• weight under 50 kg
• allergy to non-steroidal anti-inflammatory medications
• past medical history of liver disease, renal disease, peptic ulcer disease or recent gastrointestinal bleed,
• daily narcotic pain use
• positive cultures for gonorrhea or chlamydia.

Sponsors & Collaborators

• OhioHealth: lead

MeSH Terms

Interventions

Ketorolac; Ketorolac Tromethamine

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: John O. Elliott PhD, MPH Research Specialist Medical Education
• Organization: OhioHealth

john.elliott@ohiohealth.com

614-566-3643

Study Officials

• Michelle Crawford, MD

  OhioHealth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• 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: November 30, 2016
• First Posted: January 26, 2017
• Study Start: July 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: September 26, 2018
• Results First Posted: September 26, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share