Paracetamol on Postoperative Nausea and Vomiting

Postoperative Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03588338
• Other study ID #: 2017/1081
• Status: Completed
• Phase: Phase 4
• Start date: July 20, 2018
• Est. completion date: August 21, 2018

Study information

• Verified date: August 2020
• Source: Aydin Adnan Menderes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 21, 2018
• Est. primary completion date: August 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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

Locations

Country	Name	City	State
Turkey	Ozlem Kocaturk	Aydin

Sponsors (1)

Lead Sponsor	Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preventing of postoperative nausea and vomiting	Preventing of postoperative nausea and vomiting in postoperative care unit	First 24 hours postoperatively