Ibuprofen and Acetaminophen Versus Ibuprofen and Acetaminophen Plus Hydrocodone for Analgesia After Cesarean Section

• Status: Completed
• Trial end date: 2018-04-10
• Target enrollment: 0
• Participant gender: Female

Summary

Postpartum patients delivered by cesarean section will be randomized to NSAIDS Vs NSAIDS plus opioid

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Treatments: Acetaminophen; Ibuprofen

Criteria

Inclusion Criteria:

• English or Spanish speaker women who had a cesarean section

Exclusion Criteria:

• 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