Phase 4 N=71 Randomized Triple-blind Treatment

Oral Ketorolac for Pain Relief During IUD Insertion

Contraception

Bottom Line

View on ClinicalTrials.gov: NCT03031795 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2018

Primary outcome: Primary: Pain Before, During and After IUD Placement — 4.1; 4.5; 0.4; 0.7 units on a scale — p=< 0.05

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Ketorolac (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: OhioHealth
Primary completion: Mar 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Before, During and After IUD Placement	4.1; 4.5; 0.4; 0.7; 2.7; 3.2	< 0.05 sig

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03031795). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.