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Phase 4 Completed N=132 Randomized Triple-blind Supportive Care

RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Cesarean Pain Relief

Cesarean section · Pain, Postoperative
Source: ClinicalTrials.gov NCT02046382 ↗
Enrolled (actual)
132
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcomePrimary: Total Oxycodone (mg) — 47.0; 65.0 mg
◆ Published Evidence
Established
49citations · ~5 / year
Randomized controlled trial of intravenous acetaminophen for postcesarean delivery pain control.
American journal of obstetrics and gynecology · 2017 · Likely link

Summary

This study is being done to evaluate the scheduled use of intravenous (IV) acetaminophen among cesarean section patients. The study hopes to find out if patients who receive scheduled IV acetaminophen for 48 hours following delivery have lower self-reported pain scores and use less narcotic pain medication than patients who do not receive IV acetaminophen.

Linked Publications

  • Randomized controlled trial of intravenous acetaminophen for postcesarean delivery pain control.
    American journal of obstetrics and gynecology · 2017 · 49 citations · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Total Oxycodone (mg)
47.0; 65.0
SECONDARY
Number of Participants With Narcotic Associated Side Effects
17; 9
SECONDARY
Length of Stay
78; 78

Eligibility Criteria

Inclusion Criteria

  • Age greater than or equal to 18 years
  • Scheduled cesarean section delivery
  • Patient of TriHealth's Faculty Medical Center or Tri-State Maternal Fetal Medicine Associates
  • Singleton pregnancy
  • Term delivery (greater than or equal to 37 weeks)
  • Spinal/epidural anesthesia with epidural analgesia (duramorph)
  • Use of pfannenstiel incision

Exclusion Criteria

  • Weight less than 50 kg
  • Allergy to study drugs (acetaminophen, oxycodone, duramorph, NSAIDS)
  • Multiple gestation pregnancy
  • Cesarean section for pre-term delivery (less than 37 weeks)
  • Fetal anomalies
  • Inability to use epidural duramorph at time of procedure
  • General anesthesia used
  • Vertical skin incision
  • Opioid addiction
  • Liver dysfunction (hepatitis, HELLP (hemolysis, elevated liver enzymes, and low platelet count), preeclampsia)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02046382) and the linked publication. 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. Informational only — not medical advice.

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