DrugLib.com — Drug Information Portal

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



IV Acetaminophen for Acute Post Operative Pain in C-Section Patients

Information source: Montefiore Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post-operative Pain

Intervention: IV Acetaminophen (Drug); Saline as placebo (Other)

Phase: Phase 4

Status: Recruiting

Sponsored by: Montefiore Medical Center

Official(s) and/or principal investigator(s):
Jeffrey Bernstein, MD, Principal Investigator, Affiliation: Montefiore Medical Center

Overall contact:
Jeffrey Bernstein, MD, Phone: 718-920-4316, Email: jbernste@montefiore.org

Summary

Post-operative pain management after C-section is an important topic as the number of elective c-sections increases each year. Pain is managed either by giving opioids or by using non-opioids. The purpose of this study is to evaluate the effectiveness of IV Acetaminophen in pain relief and its impact in the usage of post-operative opioid requirements and opioid associated complications. The hypothesis is that four doses of IV Acetaminophen in conjunction with intrathecal or epidural morphine given to the patients after c-section will reduce post-operative opioid requirements and opioid associated complications.

Clinical Details

Official title: Double Blinded Randomized Placebo Controlled Study in Evaluating the Effectiveness of IV Acetaminophen for Acute Post Operative Pain in C-Section Patients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Opioid requirements in cesarean section (c-section) patient population

Secondary outcome:

Visual Analog Score (VAS) pain score

Sedation level

Adverse events (nausea, vomiting, pruritus and breathing difficulties) after the surgery

Number of patient-controlled analgesia (PCA) attempts

Re-hospitalization

Pain medication usage

Detailed description: Most of the opioids used are centrally acting drugs like morphine or its derivatives. The most common adverse reactions related to systemic administration of opioids are sedation, itching, constipation and less commonly, respiratory depression. One of the other management strategies for the pain control is the use of non-steroidal anti-inflammatory drugs (NSAIDS). Frequent use of NSAIDS is also associated with complications, such as gastric ulcer and platelet dysfunction. When compared to other non-NSAIDS, IV acetaminophen is a relatively safer drug with quicker onset of action. In an earlier conducted study, the onset of action of analgesia for a bolus dose of IV acetaminophen is 3 minutes. IV acetaminophen is FDA approved for management of mild to moderate pain. An adverse reaction associated with the prolonged usage of IV acetaminophen is hepatic injury. The most common adverse events encountered during previous clinical trials were nausea, vomiting, headache and insomnia.

Eligibility

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

Criteria:

Inclusion Criteria:

- Elective full term CS patients

- Age 18 and above

- ASA I-III

Exclusion Criteria:

- Allergic reaction to IV acetaminophen

- Not able to understand and sign the research consent

- Pregnancy induced hypertension or pre-eclampsia patients

- Planned intensive care admission patients

- Patients with severe hepatic impairment or active liver diseases (Two fold increase

in any of the liver enzymes)

- Patients with serum creatinine>2mg/dl

- For nursing mothers, any evidence of hepatic dysfunction of the new born

Locations and Contacts

Jeffrey Bernstein, MD, Phone: 718-920-4316, Email: jbernste@montefiore.org

Montefiore Medical Center- Weiler, Bronx, New York 10467, United States; Recruiting
Jeffrey Bernstein, MD, Phone: 718-920-4316, Email: jbernste@montefiore.org
Jeffrey Bernstein, MD, Principal Investigator
Additional Information

Starting date: November 2013
Last updated: February 19, 2014

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