Increased Ketorolac Administration After Cesarean Section and Its Effect on Opioid Use: a Randomized Control Trial

NCT03678675 | Completed Phase 3 Results FDA Drug

• 1 other identifier: Ketorolac Pain Study
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy of increased ketorolac in reducing opioid use after cesarean section.

Conditions

Post-operative Pain; Post-partum Pain; Cesarean Section Complications

Keywords

ketorolac; opiate; cesarean section

Outcome Measures

Primary Outcomes (1)

• The Total Morphine Milligram Equivalents (MME) Used in the First 72 Postoperative Hours

  The amount of MME's will be monitored for each group. MME's will be determined by the amount of opiate mediations administered. The MME value can range from 0 to typically 200 MME's, however there is no upper limit of measureable MME's. The MME's for each patient will be a sum of MME's administered throughout the course of the hospitalization.

  Within 72 postoperative hours

Secondary Outcomes (6)

• Number of Participants With a Pain Score Greater Than 3

  2 weeks

• The Number of Patients That Used no Opioid Postoperatively

  Within 72 post-operative hours

• Postoperative Change in Hematocrit

  Change in pre-operative hematocrit to POD1 hematocrit

• Change in Creatinine

  Change in creatinine from POD1 to POD2

• Postoperative Satisfaction With Inpatient Pain Control

  Inpatient pain control satisfaction as reported at two weeks postpartum

Study Arms (2)

Standard Protocol

NO INTERVENTION

Subjects randomized to the standard group will receive the standard postoperative pain protocol that is currently used at Tufts Medical Center. It includes two doses of IV Ketorolac every 6 hours as needed for postoperative pain. Ibuprofen would be ordered 6 hours following the last dose after the last study drug.

Ketorolac Protocol

EXPERIMENTAL

Subjects randomized to the Ketorolac protocol will receive the study postoperative pain protocol. This includes 6 doses of IV Ketorolac, scheduled every 6 hours. The first dose is administered in the operating room or post-operative care unit.

Drug: Ketorolac

Interventions

Ketorolac DRUG

The intervention is a protocol of scheduled IV Ketorolac administered postoperatively.

Ketorolac Protocol

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women presenting for care at Tufts Medical Center as an outpatient in obstetrics clinic or on Labor and Delivery.
• The subject must have had a cesarean section for any indication at Tufts Medical Center to be randomized to the study
• The subject is willing to have a phone call follow up conversation 2 weeks after their surgery.

You may not qualify if:

• Patients with allergy to ketorolac, NSAIDS or aspirin
• Patients with peptic ulcer disease, preexisting kidney or liver disease.
• Duramorph is not used as the anesthetic for the spinal/epidural during the cesarean section.
• Patient is hemodynamically unstable due to hemorrhage.
• Patient requires therapeutic anticoagulation in the post-operative period
• Patients with peripartum cardiomyopathy
• Provider decision to exclude patient.
• Patient diagnosis of chronic hypertension, gestational hypertension, preeclampsia, HELLP syndrome, or eclampsia
• A study subject may participate in another research study while participating in this research study.

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

• Hostage J, Kolettis D, Sverdlov D, Ludgin J, Drzymalski D, Sweigart B, Mhatre M, House M. Increased Scheduled Intravenous Ketorolac After Cesarean Delivery and Its Effect on Opioid Use: A Randomized Controlled Trial. Obstet Gynecol. 2023 Apr 1;141(4):783-790. doi: 10.1097/AOG.0000000000005120. Epub 2023 Mar 9.

  PMID: 36897140 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ketorolac

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jean Hostage
• Organization: Tufts Medical Center

jeanhostage@gmail.com

617-636-4549

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The subjects, care providers, and investigators will be blinded to the assignments of groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 19, 2018
• Study Start: May 30, 2019
• Primary Completion: January 31, 2022
• Study Completion: June 30, 2022
• Last Updated: August 18, 2022
• Results First Posted: August 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)