Ibuprofen Versus Ketorolac for Pain Relief During Hysterosalpingogram

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 .

Study Overview

• Status: Not yet recruiting
• Conditions: Infertility, Female
• Intervention / Treatment: Drug: Ibuprofen 800 mg oral; Drug: Ketorolac 30mg oral

Detailed Description

Describe step-by-step how the study will be conducted from beginning to end

1. After IRB approval, the research pharmacist will provide motrin and ketorolac in identical packets labeled 1-88, after receiving the randomization strategy/number set from the research monitor.
2. REI physician on the protocol will screen patient for inclusion/exclusion from study at new patient consult or at future follow up visit when need for HSG is decided.
3. If patient pt screens eligible, discuss study. If elects participation then consent patient and randomize to group.

4. At time of scheduling HSG, patient will need to remind nursing that they are in HSG study. Nursing should also have the list of patients to reference when scheduling HSGs. Patients in the study will need to check in at the REI clinic 70 minutes prior to HSG in order to take their meds 60 minutes prior to scheduled procedure time. At same visit, REI RN will perform urine pregnancy test as previously scheduled.

   a. meds will be kept in a locked cabinet in the REI research office in opaque sealed envelopes.

5. Patient will then go check into Radiology for their HSG.
6. HSG will be performed per standard clinical protocol. The HSG will be performed by REI physicians and OB/GYN residents (who are rotating on REI), which are the current standard of practice.

7. A nurse or provider associated with the study will need to be at the HSG for the sole purpose of study assistance. The provider performing the HSG, the study personnel recording pain levels, and the fluro tech will not be aware of the type of pre-procedural medication the patient received. The nurse or provider of study personnel will do the following:

   1. time the procedure from placement of speculum through deflation of catheter balloon and removal of catheter. Record time in seconds (can write mins:seconds and then convert later).
   2. record who performed the procedure, if a tenaculum had to be used, and if an attending had to take over the procedure
   3. help patient record pain scale marks on the VAS sheet at the designated time periods.

7. For clarity- there will be at least three providers at each HSG for study enrolled patients.

1. A provider who does the HSG
2. A fluoro technician to capture fluoro images for teh HSG
3. A study affialitied person to record pain scores for patient as above 8. At the conclusion of study recruitment, the blinded researchers will gain access to the subject ID's cohort status (ibuprofen vs ketorolac), and study analysis will be undertaken.

• Study Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Bruce Pier, MD; Phone Number: 253-968-3276; Email: bruce.d.pier3.mil@mail.mil

Study Locations

• United States
  • Washington
    • Tacoma, Washington, United States, 98431
      • Madigan Army Medical Center
      • Contact: Bruce Pier, MD; Phone Number: 253-968-3276; Email: bruce.d.pier3.mil@mail.mil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ibuprofen; 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; 1 hour before HSG; Other Names: Advil; Motrin
EXPERIMENTAL: Ketorolac; 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; 1 hour before HSG; Other Names: Toradol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain during contrast infiltration	Pain on Visual Analogue Scale (0-100)	Between 0 seconds and 5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain at baseline (before procedure start)	Pain on Visual Analogue Scale (0-100)	Between 0 seconds and 5 minutes
Pain with HSG catheter placement	Pain on Visual Analogue Scale (0-100)	Between 0 seconds and 5 minutes
Pain at completion of HSG	Pain on Visual Analogue Scale (0-100)	Between 0 seconds and 5 minutes
Pain 5 minutes following HSG	Pain on Visual Analogue Scale (0-100)	5 minutes after procedure

Collaborators and Investigators

• Sponsor: Madigan Army Medical Center
• Investigators: Principal Investigator: Bruce Pier, Madigan Chief of REI, Department of OBGYN

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 31, 2022
• Primary Completion (ANTICIPATED): October 15, 2022
• Study Completion (ANTICIPATED): January 1, 2023

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (ACTUAL): January 13, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 13, 2022
• Last Update Submitted That Met QC Criteria: January 11, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: ibuprofen; ketorolac; hysterosalpingogram
• Additional Relevant MeSH Terms: Infertility; Infertility, Female; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketorolac; Ibuprofen
• Other Study ID Numbers: 221063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No