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TerminatedPhase 4

Ibuprofen Versus Ketorolac for Pain Relief During Hysterosalpingogram

Key facts

Who runs it
Madigan Army Medical Center
Where
Tacoma, United StatesSee the site
Trial code
Status
Terminated
Phase
Phase 4
People taking part
12 people enrolled
Started
24 Mar 2022
Ended
10 Oct 2024
Type of study
Interventional, 2 groups
Treatments tested
  • Ibuprofen 800 mg oral
  • Ketorolac 30mg oral
Record updated
24 December 2024
Why it stopped
IRB voted to terminate the protocol for noncompliance

Who can take part

Age
18 years to 45 years
Sex
Women only
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • patients with history of previous HSG performed
  • use of pain medications within 12 hours of the scheduled procedure
  • patients with contrast allergy or other contraindications to HSG
  • active renal or hepatic disease
  • patients with chronic pain conditions (fibromyalgia, complex regional pain syndrome, etc.)
  • Non-English speaking
  • patients with contraindications to NSAID use
  • Patients with the following:
  • unwilling to consent
  • positive urine pregnancy test within 24 hours of the scheduled procedure
  • chronic narcotic users
  • patients with unknown uterine anatomical pathology

Where in United States

  • Madigan Army Medical CenterTacoma, United States

About the trial

What the trial wants to find out

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 .

The 2 groups in the trial

  • IbuprofenTreatment being tested

    Patients randomized to this arm will receive an identical capsule to the other patient arm, and receive 800mg ibuprofen 1 hour before HSG.

    Treatment: Ibuprofen 800 mg oral

  • KetorolacTreatment being tested

    Patients randomized to this arm will receive an identical capsule to the other patient arm, and receive 30mg ketorolac 1 hour before HSG.

    Treatment: Ketorolac 30mg oral

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
24 December 2024