Ibuprofen Versus Ketorolac for Pain Relief During Hysterosalpingogram

NCT05190341 | Terminated Phase 4 FDA Drug

• 1 other identifier: 221063
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Infertility, Female

Keywords

hysterosalpingogram; ibuprofen; ketorolac

Outcome Measures

Primary Outcomes (1)

• Pain during contrast infiltration

  Pain on Visual Analogue Scale (0-100)

  Between 0 seconds and 5 minutes

Secondary Outcomes (4)

• Pain at baseline (before procedure start)

  Between 0 seconds and 5 minutes

• Pain with HSG catheter placement

  Between 0 seconds and 5 minutes

• Pain at completion of HSG

  Between 0 seconds and 5 minutes

• Pain 5 minutes following HSG

  5 minutes after procedure

Study Arms (2)

Ibuprofen

EXPERIMENTAL

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

Drug: Ibuprofen 800 mg oral

Ketorolac

EXPERIMENTAL

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

Drug: Ketorolac 30mg oral

Interventions

Ibuprofen 800 mg oral DRUG

1 hour before HSG

Also known as: Advil, Motrin

Ibuprofen

Ketorolac 30mg oral DRUG

1 hour before HSG

Also known as: Toradol

Ketorolac

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Madigan Army Medical Center: lead

Study Sites (1)

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

Ibuprofen; Ketorolac; Ketorolac Tromethamine

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bruce Pier

  Madigan Chief of REI, Department of OBGYN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Research pharmacist has provided either 800mg ibuprofen or 30mg ketorolac into oral capsules, and randomized sets of pills in packages 1-88. Research physicians and patients blinded which pill sets contain which drug. Will be revealed after data collection complete.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial- 88 sequential patients randomized to receive either ibuprofen on ketorolac 1 hr before HSG

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: January 13, 2022
• Study Start: March 24, 2022
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)