Paracetamol on Postoperative Nausea and Vomiting

Phase 4

Completed

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: Perfalgan; Drug: Control

• Registration Number: NCT03588338
• Lead Sponsor: Aydin Adnan Menderes University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-07-05
• Study First Submitted QC: 2018-07-05
• Study First Posted: 2018-07-17
• Study Start: 2018-07-20
• Primary Completion: 2018-08-20
• Study Completion: 2018-08-21
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-11
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Perfalgan	Perfalgan	1.5 mg/kg intravenous, intraoperative (20 min before end of the surgery)
Perfalgan	Control	1.5 mg/kg intravenous, intraoperative (20 min before end of the surgery)
Control	Perfalgan	1.5 mg/kg intravenous, intraoperative (20 min before end of the surgery)
Control	Control	1.5 mg/kg intravenous, intraoperative (20 min before end of the surgery)

Primary Outcome Measures

Name	Time	Method
Preventing of postoperative nausea and vomiting	First 24 hours postoperatively	Preventing of postoperative nausea and vomiting in postoperative care unit

Trial Locations

Locations (1)

Ozlem Kocaturk; 🇹🇷 Aydin, Turkey