Status:
COMPLETED
Ibuprofen and Acetaminophen Versus Ibuprofen and Acetaminophen Plus Hydrocodone for Analgesia After Cesarean Section
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Opioid Use
Pain, Postoperative
Eligibility:
FEMALE
18-50 years
Phase:
PHASE4
Brief Summary
Postpartum patients delivered by cesarean section will be randomized to NSAIDS Vs NSAIDS plus opioid
Detailed Description
Women will be approached priors to discharge from the hospital, if they meet inclusion criteria and consent for the study, they will be randomized to one of two possible analgesic regimens. They will ...
Eligibility Criteria
Inclusion
- English or Spanish speaker women who had a cesarean section
Exclusion
- Inability or refusal to provide informed consent.
- Reported current or prior opioid or benzodiazepine use disorder, including urine drug screen positive for a non prescribed opioid or benzodiazepine upon admission or during prenatal care.
- Current treatment with methadone, buprenorphine or buprenorphine plus naloxone.
- Known alcoholism disorder.
- Severe renal or hepatic impairment.
- Known creatinine \> 1.5 at the time of delivery or severe proteinuria leading to diagnosis of renal disease prior to delivery.
- Severe peptic ulcer disease
- Severe asthma (if patient has asthma but has previously tolerated NSAIDS, she will be allowed to participate)
- Known CYP450/CY92D6 mutation conferring opioid ultra-rapid metabolizer status.
- Allergy to any of the study drugs (anaphylaxis).
- Incarcerated or institutionalized patients.
- Inability to follow up as outpatient in our outpatient clinic.
- wound dehiscence or infection diagnosed prior to discharge from the hospital
- wound vac placed prior to discharge from the hospital
Key Trial Info
Start Date :
December 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2018
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT03372382
Start Date
December 13 2017
End Date
April 10 2018
Last Update
July 2 2019
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030