To evaluate the efficacy of increased ketorolac in reducing opioid use after cesarean section.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
148
The intervention is a protocol of scheduled IV Ketorolac administered postoperatively.
Tufts Medical Center
Boston, Massachusetts, United States
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.
Time frame: Within 72 postoperative hours
Number of Participants With a Pain Score Greater Than 3
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.
Time frame: 2 weeks
The Number of Patients That Used no Opioid Postoperatively
The number of patients in each arm that required no opioids for pain control postoperatively.
Time frame: Within 72 post-operative hours
Postoperative Change in Hematocrit
The change in patient hematocrit from baseline to POD1
Time frame: Change in pre-operative hematocrit to POD1 hematocrit
Change in Creatinine
The change in patient's creatinine from POD1 to POD2
Time frame: Change in creatinine from POD1 to POD2
Postoperative Satisfaction With Inpatient Pain Control
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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.
Time frame: Inpatient pain control satisfaction as reported at two weeks postpartum
Postoperative Satisfaction With Their Inpatient Postpartum Care.
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.
Time frame: Satisfaction with inpatient care as reported at two weeks postpartum