Skip to main content
OpenTrials
Completed

NCT Number: NCT03678675

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Post-operative Pain Cesarean Section Complications Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post-partum Pain Postoperative Complications Signs and Symptoms

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

About this study

This was a single-center, randomized, double-blind, parallel-group trial to assess pain management following cesarean section with increased ketorolac versus placebo. All patients undergoing cesarean section with neuraxial anesthesia received two doses of 30mg IV ketorolac postoperatively per hospital protocol and were then randomized to receive an additional four doses of 30 mg of IV ketorolac or placebo every 6 hours. The primary outcome was the total morphine milligram equivalents (MME) used in the first 72 postoperative hours. Secondary outcomes included the number of patients that used no opioid postoperatively, postoperative pain scores, postoperative change in hematocrit and creatinine, and postoperative satisfaction with inpatient care and pain management. A sample size of 74 per group (n=148) was planned.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.

Treatment and study plan

Ketorolac

Drug

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

Primary outcomes

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

    Time frame: Within 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.

Secondary outcomes

  1. Number of Participants With a Pain Score Greater Than 3

    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. Pain scores were collected by postpartum nursing staff per institutional policy. The number of patients with a pain score greater than 3 will be reported. A pain score greater than 3 was chosen as a cutoff as this is the pain score at which an opioid may be indicated for analgesia at our institution.

  2. The Number of Patients That Used no Opioid Postoperatively

    Time frame: Within 72 post-operative hours

    The number of patients in each arm that required no opioids for pain control postoperatively.

  3. Postoperative Change in Hematocrit

    Time frame: Change in pre-operative hematocrit to POD1 hematocrit

    The change in patient hematocrit from baseline to POD1

  4. Change in Creatinine

    Time frame: Change in creatinine from POD1 to POD2

    The change in patient's creatinine from POD1 to POD2

  5. Postoperative Satisfaction With Inpatient Pain Control

    Time frame: Inpatient pain control satisfaction as reported at two weeks postpartum

    Two weeks after cesarean section, subjects were contacted by telephone to complete a survey on postpartum pain management. At least three attempts were made to contact subjects by telephone. In the follow-up phone call, patients were asked to rate their satisfaction with their postpartum care: very satisfied, satisfied, neutral, dissatisfied, or very dissatisfied. The number below describes the number of patients who reported they were "very satisfied" with their care.

  6. Postoperative Satisfaction With Their Inpatient Postpartum Care.

    Time frame: Satisfaction with inpatient care as reported at two weeks postpartum

    Two weeks after cesarean section, subjects were contacted by telephone to complete a survey on their overall postpartum care. At least three attempts were made to contact subjects by telephone. In the follow-up phone call, patients were asked to rate their satisfaction with their postpartum care: very satisfied, satisfied, neutral, dissatisfied, or very dissatisfied. The number below describes the number of patients that reported they were very satisfied with their care.

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 19, 2018
Registry last updated
Aug 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.