Oral Ketorolac for Pain Relief During IUD Insertion

Oral Ketorolac for Pain Relief During IUD Insertion: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: Placebo; Drug: Ketorolac

Detailed Description

In the United States, 10% of women choose an intrauterine device (IUD) for contraception. With typical use, unintended pregnancy rates in the first year of IUD contraception are 0.8% (Copper T) and 0.2% (LNG). It is known that long-acting, reversible contraception methods reduce the long-term cost of unintended pregnancies. A common deterrent to intrauterine contraception is the fear of pain during placement. Methods of pain relief during IUD insertion must be fast-acting but have minimal sedation. There have been many attempts to find effective pain relief during IUD placement. Neither ibuprofen nor naproxen have been shown to be effective in reducing pain. Misoprostol has been used to increase cervical ripening; however, pain was not decreased, and side effects of nausea and vomiting were increased. Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID) that works by reversibly inhibiting cyclooxygenase-1 and 2.Time to peak plasma concentration ketorolac in the oral form is 44 minutes. Studies have shown that one dose of ketorolac can be as potent as morphine. Ketorolac is also well established for pain control in the immediate post-operative period. A recent study showed that intramuscular ketorolac wais effective in reducing pain after IUD insertion, but 20% of the participants reported that after the procedure, the injection site was as painful as the IUD placement. The current study was designed to evaluate if there is reduced pain during IUD placement using oral ketorolac 40-60 minutes before the procedure compared to a placebo.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental; ketorolac, oral, 20 mg, 1 dose, 45 minutes prior to IUD placement	Drug: Ketorolac; Oral Tablet; Other Names: Toradol
Placebo Comparator: placebo; look alike placebo	Drug: Placebo; Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: OhioHealth
• Investigators: Principal Investigator: Michelle Crawford, MD, OhioHealth

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: November 30, 2016
• First Submitted That Met QC Criteria: January 25, 2017
• First Posted (Estimate): January 26, 2017

Study Record Updates

• Last Update Posted (Actual): September 26, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: intrauterine device
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketorolac
• Other Study ID Numbers: OH1-13-00503

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD Plan Description

We will share our published manuscript upon request:

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. Journal of Obstetrics and Gynaecology Canada 2017, Dec;39(12):1143-1149. doi: 10.1016/j.jogc.2017.05.014.