Paracetamol on Postoperative Nausea and Vomiting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-20

Study Completion Date

2018-08-21

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.

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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.

Conditions

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Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Perfalgan

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

Group Type ACTIVE_COMPARATOR

Perfalgan

Intervention Type DRUG

For postoperative pain

Control

Intervention Type DRUG

For postoperative nausea and vomiting

Control

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

Group Type OTHER

Perfalgan

Intervention Type DRUG

For postoperative pain

Control

Intervention Type DRUG

For postoperative nausea and vomiting

Interventions

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Perfalgan

For postoperative pain

Intervention Type DRUG

Control

For postoperative nausea and vomiting

Intervention Type DRUG

Other Intervention Names

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Paracetamol Saline

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes