Paracetamol on Postoperative Nausea and Vomiting

Study Overview
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Brief Summary
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The drugs with both high potency and low side effects are preferred in the prevention of postoperative nausea and vomiting (PONV) which is a common problem. This prospective randomized study aimed to compare the efficacy of paracetamol on PONV in adults undergoing maxillofacial surgery.

Detailed Description
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One hundred-twenty patients are randomly divided into two groups; the paracetamol group who received the IV infusion of paracetamol (1.5 ml/kg); and the metoclopramide group who received the IV infusion of saline (1.5 mg/kg). The presence of vomiting and the actions indicative of nausea, such as repeated gagging or spitting, within 24h following general anesthesia are defined as PONV. All PONV episodes and postoperative pain scores are recorded during 24h postoperatively. The postoperative 0-4h and 4-24h are defined as early and late postoperative period, respectively. Intravenous 4 mg ondansetron as rescue antiemetic drug is administered in case of two or more vomiting episodes.

Official Title
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The Effect of Paracetamol on Postoperative Nausea and Vomiting Following Maxillofacial Surgery: a Prospective, Randomised, Double-blind Study

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Drug: Perfalgan
* Drug: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA (the classification of the American Society of Anesthesiologists) physical status I-II Patients who scheduled for elective maxillofacial surgery under general anesthesia Exclusion Criteria: Patients with a history of allergy to any of the study medications (opioid, general anesthetic agents or paracetamol) History of opioid use, hepatic or renal disease, coronary, psychotic and neurologic diseases Use of antiemetic, antihistaminic, analgesic or corticosteroid 24 hours (h) prior to surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Perfalgan<br>1.5 mg/kg intravenous, intraoperative (20 min before end of the surgery) | Drug: Perfalgan<br>* For postoperative pain<br>* Other names: Paracetamol;Drug: Control<br>* For postoperative nausea and vomiting<br>* Other names: Saline;|
| Other: Control<br>1.5 mg/kg intravenous, intraoperative (20 min before end of the surgery) | Drug: Perfalgan<br>* For postoperative pain<br>* Other names: Paracetamol;Drug: Control<br>* For postoperative nausea and vomiting<br>* Other names: Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preventing of postoperative nausea and vomiting | Preventing of postoperative nausea and vomiting in postoperative care unit | First 24 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PONV, Paracetamol