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Ibuprofen Versus Ketorolac for Pain Relief During Hysterosalpingogram

Primary Purpose

Infertility, Female

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ibuprofen 800 mg oral
Ketorolac 30mg oral
Sponsored by
Madigan Army Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infertility, Female focused on measuring hysterosalpingogram, ibuprofen, ketorolac

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Madigan Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ibuprofen

Ketorolac

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain during contrast infiltration
Pain on Visual Analogue Scale (0-100)

Secondary Outcome Measures

Pain at baseline (before procedure start)
Pain on Visual Analogue Scale (0-100)
Pain with HSG catheter placement
Pain on Visual Analogue Scale (0-100)
Pain at completion of HSG
Pain on Visual Analogue Scale (0-100)
Pain 5 minutes following HSG
Pain on Visual Analogue Scale (0-100)

Full Information

First Posted
October 29, 2021
Last Updated
January 11, 2022
Sponsor
Madigan Army Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05190341
Brief Title
Ibuprofen Versus Ketorolac for Pain Relief During Hysterosalpingogram
Official Title
Ibuprofen Versus Ketorolac for Pain Relief During Hysterosalpingogram
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 31, 2022 (Anticipated)
Primary Completion Date
October 15, 2022 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Madigan Army Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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 .
Detailed Description
Describe step-by-step how the study will be conducted from beginning to end 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. 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. If patient pt screens eligible, discuss study. If elects participation then consent patient and randomize to group. 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. Patient will then go check into Radiology for their HSG. 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. 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: 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). record who performed the procedure, if a tenaculum had to be used, and if an attending had to take over the procedure 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. A provider who does the HSG A fluoro technician to capture fluoro images for teh HSG 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
Keywords
hysterosalpingogram, ibuprofen, ketorolac

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Randomized controlled trial- 88 sequential patients randomized to receive either ibuprofen on ketorolac 1 hr before HSG
Masking
ParticipantCare ProviderInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ibuprofen
Arm Type
Experimental
Arm Description
Patients randomized to this arm will receive an identical capsule to the other patient arm, and receive 800mg ibuprofen 1 hour before HSG.
Arm Title
Ketorolac
Arm Type
Experimental
Arm Description
Patients randomized to this arm will receive an identical capsule to the other patient arm, and receive 30mg ketorolac 1 hour before HSG.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen 800 mg oral
Other Intervention Name(s)
Advil, Motrin
Intervention Description
1 hour before HSG
Intervention Type
Drug
Intervention Name(s)
Ketorolac 30mg oral
Other Intervention Name(s)
Toradol
Intervention Description
1 hour before HSG
Primary Outcome Measure Information:
Title
Pain during contrast infiltration
Description
Pain on Visual Analogue Scale (0-100)
Time Frame
Between 0 seconds and 5 minutes
Secondary Outcome Measure Information:
Title
Pain at baseline (before procedure start)
Description
Pain on Visual Analogue Scale (0-100)
Time Frame
Between 0 seconds and 5 minutes
Title
Pain with HSG catheter placement
Description
Pain on Visual Analogue Scale (0-100)
Time Frame
Between 0 seconds and 5 minutes
Title
Pain at completion of HSG
Description
Pain on Visual Analogue Scale (0-100)
Time Frame
Between 0 seconds and 5 minutes
Title
Pain 5 minutes following HSG
Description
Pain on Visual Analogue Scale (0-100)
Time Frame
5 minutes after procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruce Pier, MD
Phone
253-968-3276
Email
bruce.d.pier3.mil@mail.mil
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Pier
Organizational Affiliation
Madigan Chief of REI, Department of OBGYN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruce Pier, MD
Phone
253-968-3276
Email
bruce.d.pier3.mil@mail.mil

12. IPD Sharing Statement

Plan to Share IPD
No

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Ibuprofen Versus Ketorolac for Pain Relief During Hysterosalpingogram

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