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Completed

NCT Number: NCT03588338

Paracetamol on Postoperative Nausea and Vomiting

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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Key information

Conditions

Postoperative Nausea and Vomiting Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ozlem Kocaturk

Aydin, 09100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

perfalgan

Drug

For postoperative pain

Other names: Paracetamol

Control

Drug

For postoperative nausea and vomiting

Other names: Saline

Primary outcomes

  1. Preventing of postoperative nausea and vomiting

    Time frame: First 24 hours postoperatively

    Preventing of postoperative nausea and vomiting in postoperative care unit

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 17, 2018
Registry last updated
Aug 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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