Paracetamol on Postoperative Nausea and Vomiting

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: August 20, 2018

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.

Interventions

  • Drug: Perfalgan
    • For postoperative pain
  • Drug: Control
    • For postoperative nausea and vomiting

Arms, Groups and Cohorts

  • Active Comparator: Perfalgan
    • 1.5 mg/kg intravenous, intraoperative (20 min before end of the surgery)
  • Other: Control
    • 1.5 mg/kg intravenous, intraoperative (20 min before end of the surgery)

Clinical Trial Outcome Measures

Primary Measures

  • Preventing of postoperative nausea and vomiting
    • Time Frame: First 24 hours postoperatively
    • Preventing of postoperative nausea and vomiting in postoperative care unit

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Aydin Adnan Menderes University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ozlem Kocaturk, Faculty of Dentisty Oral and Maxillofacial Surgery – Aydin Adnan Menderes University
  • Overall Official(s)
    • Adnan Menderes University, Study Director, Aydin Adnan Menderes University

References

Cok OY, Eker HE, Pelit A, Canturk S, Akin S, Aribogan A, Arslan G. The effect of paracetamol on postoperative nausea and vomiting during the first 24 h after strabismus surgery: a prospective, randomised, double-blind study. Eur J Anaesthesiol. 2011 Dec;28(12):836-41. doi: 10.1097/EJA.0b013e32834c580b.

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