IV Acetaminophen for Acute Post Operative Pain in C-Section Patients
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
66 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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