TerminatedPhase 4

Ibuprofen Versus Ketorolac for Pain Relief During Hysterosalpingogram

Stopped: IRB voted to terminate the protocol for noncompliance

United States12 participantsStarted 2022-03-24

Plain-language summary

Hysterosalpingogram (HSG) testing is a vital part of the workup for infertility patients. It is often noted to be biggest pain that patients undergo during the workup. Several studies have attempted to find a therapy that reduces pain, with non-steroidal anti-inflammatory drugs such as oral ibuprofen the current mainstay. Our study attempts to determine which of the following NSAIDS is best at reducing pain associated with the HSG procedure: oral ibuprofen versus oral ketorolac .

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * English speaking * premenopausal females age 18-45 * patients currently undergoing HSG as part of routine work-up for infertility or subfertility, - - patients with negative urine pregnancy test within 24 hours of the scheduled procedure * patients having performance of HCG between menstrual cycle days 5-12n Exclusion Criteria: * Non-English speaking * patients with history of previous HSG performed * patients with contrast allergy or other contraindications to HSG * patients with contraindications to NSAID use * Patients with the following: * unwilling to consent * positive urine pregnancy test within 24 hours of the scheduled procedure * active renal or hepatic disease * chronic narcotic users * use of pain medications within 12 hours of the scheduled procedure * patients with chronic pain conditions (fibromyalgia, complex regional pain syndrome, etc.) * patients with unknown uterine anatomical pathology

What they're measuring

Pain during contrast infiltration

Timeframe: Between 0 seconds and 5 minutes

Trial details

NCT IDNCT05190341

SponsorMadigan Army Medical Center

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2024-10-10