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Oral Ketorolac for Pain Relief During IUD Insertion

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ClinicalTrials.gov Identifier: NCT03031795
Recruitment Status : Completed
First Posted : January 26, 2017
Results First Posted : September 26, 2018
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
OhioHealth

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.

Condition or disease Intervention/treatment Phase
Contraception Drug: Ketorolac Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Oral Ketorolac for Pain Relief During IUD Insertion: A Randomized Controlled Trial
Study Start Date : July 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ketorolac

Arm Intervention/treatment
Experimental: experimental
ketorolac, oral, 20 mg, 1 dose, 45 minutes prior to IUD placement
Drug: Ketorolac
Oral Tablet
Other Name: Toradol

Placebo Comparator: placebo
look alike placebo
Drug: Placebo
Oral Tablet




Primary Outcome Measures :
  1. Pain Before, During and After IUD Placement [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031795


Sponsors and Collaborators
OhioHealth
Investigators
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Principal Investigator: Michelle Crawford, MD OhioHealth

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Responsible Party: OhioHealth
ClinicalTrials.gov Identifier: NCT03031795     History of Changes
Other Study ID Numbers: OH1-13-00503
First Posted: January 26, 2017    Key Record Dates
Results First Posted: September 26, 2018
Last Update Posted: September 26, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.


Keywords provided by OhioHealth:
intrauterine device

Additional relevant MeSH terms:
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Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action