Phase 4
N=170
Ibuprofen and Acetaminophen Versus Ibuprofen and Acetaminophen Plus Hydrocodone for Analgesia After Cesarean Section
Opioid Use · Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT03372382 ↗Enrolled (actual)
170
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Pain Level — 12.3; 15.9 millimeters on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ibuprofen (Drug); Acetaminophen (Drug); Norco (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Level |
12.3; 15.9 | — |
| SECONDARY Patient Satisfaction |
2; 4; 3; 3; 11; 12 | — |
Summary
Postpartum patients delivered by cesarean section will be randomized to NSAIDS Vs NSAIDS plus opioid
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03372382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.