Paracetamol on Postoperative Nausea and Vomiting

Aydin Adnan Menderes University

Status and phase: Completed; Phase 4

Conditions: Postoperative Nausea and Vomiting

Treatments: Drug: Perfalgan; Drug: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03588338

2017/1081

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups

Perfalgan

Active Comparator group

Description:

1.5 mg/kg intravenous, intraoperative (20 min before end of the surgery)

Treatment:

Drug: Control

Drug: Perfalgan

Control

Other group

Description:

1.5 mg/kg intravenous, intraoperative (20 min before end of the surgery)

Treatment:

Drug: Control

Drug: Perfalgan