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Scheduled Ketorolac Administration After Cesarean Section and Its Effect on Opioid Consumption: a Randomized Control Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03678675
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : November 20, 2019
Information provided by (Responsible Party):
Tufts Medical Center

Brief Summary:

This study evaluates how a protocol of scheduled non-narcotic anesthetic used in the immediate post-operative period affects the average patient pain scale scores and the amount of oral narcotic medication administered. The objective of the study is to identify a post-operative pain control regimen that can decrease the amount of oral narcotic medications administered in the post-operative period.

The primary outcome will be the amount of morphine milligram equivalents (MME) used in each group. Secondary outcomes will include pain scores, postoperative complete blood count, and post-operative satisfaction with care received during admission.

Condition or disease Intervention/treatment Phase
Post-operative Pain Post-partum Pain Cesarean Section Complications Drug: Ketorolac Phase 3

Detailed Description:
Subjects who consented to be part of the trial will be randomized at the time of skin closure of their cesarean section to either the standard group or the study group. The standard group will receive the standard treatment of 2 doses of 30mg IV Ketorolac on an as needed basis. The study group will receive 6 doses of 30mg IV Ketorolac scheduled every 6 hours. The subject will receive her first dose in the operating room. The ob/gyn residents will be responsible for placing the orders in Sorian for either "Standard Post-Operative Pain Control" order set or the "Ketorolac Study Post Cesarean Section Pain Control" order set. Please see below for sample order sets. Pain scores will be evaluated using a visual analog pain scale every 6 hours throughout hospitalization and recorded in the electronic medical record. The amount of oral opiate medications administered for subjects in each group will be recorded in the electronic medical record as well.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: The subjects, care providers and investigators will be blinded to the assignments of groups. The investigation drug pharmacy will not be blinded.
Primary Purpose: Treatment
Official Title: Scheduled Ketorolac Administration After Cesarean Section and Its Effect on Opioid Consumption: a Randomized Control Trial
Actual Study Start Date : May 31, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
Drug Information available for: Ketorolac

Arm Intervention/treatment
No Intervention: Standard Protocol
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.
Experimental: Ketorolac Protocol
Subjects randomized to the Ketorolac protocol will receive the study postoperative pain protocol. This includes 5 doses of IV Ketorolac, scheduled every 6 hours. The first dose is administered in the operating room.
Drug: Ketorolac
The intervention is a protocol of scheduled IV Ketorolac administered postoperatively.

Primary Outcome Measures :
  1. Amount of morphine milligram equivalents (MME) administered in each arm [ Time Frame: 2 weeks ]
    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.

Secondary Outcome Measures :
  1. Pain scores [ Time Frame: 2 weeks ]
    The patient reported pain scores will be recorded and analyzed for each group. The Pain Score is determined by the patient using a visual analog scale with a range from 0-10, where 0 is no pain at all and 10 is the worst pain imaginable for the patient.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • A study subject may participate in another research study while participating in this research study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03678675

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United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Diana S Kolettis, MD    617-636-5000 ext 9043   
Sponsors and Collaborators
Tufts Medical Center

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Responsible Party: Tufts Medical Center Identifier: NCT03678675    
Other Study ID Numbers: Ketorolac Pain Study
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Tufts Medical Center:
cesarean section
Additional relevant MeSH terms:
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Ketorolac Tromethamine
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action