Scheduled Ketorolac Administration After Cesarean Section and Its Effect on Opioid Consumption: a Randomized Control Trial
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|ClinicalTrials.gov Identifier: NCT03678675|
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : July 18, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||142 participants|
|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.|
|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 :||September 2019|
|Estimated Study Completion Date :||September 2019|
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.
The intervention is a protocol of scheduled IV Ketorolac administered postoperatively.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03678675
|United States, Massachusetts|
|Tufts Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02111|
|Contact: Diana S Kolettis, MD 617-636-5000 ext 9043 firstname.lastname@example.org|