N/A N=148 Randomized Single-blind Treatment

Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery

Pain, Postoperative

Bottom Line

View on ClinicalTrials.gov: NCT02487303 ↗

Enrolled (actual)

148

Serious AEs

0.0%

Results posted

Dec 2018

Primary outcome: Primary: Cumulative Postoperative Opiate Consumption — 2.9; 3.8; 5.7 mg

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Acetaminophen Intravenous (Drug); Acetaminophen Oral (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Medical University of South Carolina
Primary completion: Jul 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Cumulative Postoperative Opiate Consumption	2.9; 3.8; 5.7	—
SECONDARY Time to First Opiate Rescue	25.3; 24.0; 21.3	—
SECONDARY VAS (Visual Analog Scale)	37.8; 44.3; 50.8	—
SECONDARY Time Discharge	48.4; 48.6; 50.5	—

Summary

This study will compare IV (intravenous) versus oral (PO) acetaminophen for postoperative pain after scheduled, elective Cesarean delivery. All patients will receive a standardized spinal anesthetic for operative anesthesia and will be randomized into one of three groups: (group 1) 1 gram IV acetaminophen every 8 hours for three doses, (group 2) 1 gram oral acetaminophen every 8 hours for three doses, or (group 3) no acetaminophen. This will be a randomized, open label study.

Eligibility Criteria

Inclusion Criteria

Parturients 18 years
Elective Cesarean delivery
Spinal anesthesia
Able to consent to the study and participate in the follow-up.

Exclusion Criteria

Weight under 50 kgs
Allergy to acetaminophen
General anesthesia
Urgent or emergent cases
Bleeding diathesis or other coagulopathy
G6PD deficiency
Liver disease
Substance abuse or dependence
HELLP syndrome
Thrombocytopenia or platelet dysfunction
History or active gastrointestinal bleeding
Acute kidney injury or chronic renal insufficiency
Contraindication/refusal to spinal anesthesia
Chronic pain
Chronic narcotic use
Illicit drug use
Allergy to any study related medications.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02487303). 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.