DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery

Information source: Medical University of South Carolina
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain, Postoperative

Intervention: Acetaminophen Intravenous (Drug); Acetaminophen Oral (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Medical University of South Carolina

Official(s) and/or principal investigator(s):
Sylvia Wilson, MD, Principal Investigator, Affiliation: Medical University of South Carolina

Overall contact:
Wanda Jones, RN, Phone: 843-792-1869, Email: joneswr@musc.edu

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.

Clinical Details

Official title: Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Total opiate consumption 24 hours following Cesarean delivery

Secondary outcome:

Time to first opiate rescue

VAS (visual analog scale)

Time discharge

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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.

Locations and Contacts

Wanda Jones, RN, Phone: 843-792-1869, Email: joneswr@musc.edu

Medical University of South Carolina, Charleston, South Carolina 29425, United States; Recruiting
Wanda Jones, RN, Phone: 843-792-1869, Email: joneswr@musc.edu
Sylvia H Wilson, MD, Principal Investigator
Additional Information

Starting date: June 2015
Last updated: June 26, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017