Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Pain, Postoperative

Treatments: Drug: Acetaminophen Oral; Drug: Acetaminophen Intravenous

Study type: Interventional

Funder types: Other

Identifiers

NCT02487303

Pro00041193

Details and patient eligibility

About

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.

Full description

This study will compare IV versus PO acetaminophen for postoperative pain in parturients after scheduled, elective Cesarean delivery. It is designed as a randomized, open label, controlled trial. 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 by a computer generated list.

Enrollment: 148 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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148 participants in 3 patient groups

Acetaminophen Intravenous

Active Comparator group

Description:

(group 1) 1 gram IV acetaminophen every 8 hours for three doses

Treatment:

Drug: Acetaminophen Intravenous

Acetaminophen Oral

Active Comparator group

Description:

(group 2) 1 gram oral acetaminophen every 8 hours for three doses

Treatment:

Drug: Acetaminophen Oral

No acetaminophen

No Intervention group

Description:

(group 3) no acetaminophen