Paracetamol on Postoperative Nausea and Vomiting
August 11, 2020 updated by: Ozlem Kocaturk, Aydin Adnan Menderes University
The Effect of Paracetamol on Postoperative Nausea and Vomiting Following Maxillofacial Surgery: a Prospective, Randomised, Double-blind Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aydin, Turkey, 09100
- Ozlem Kocaturk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 46 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Perfalgan
1.5 mg/kg intravenous, intraoperative (20 min before end of the surgery)
|
For postoperative pain
Other Names:
For postoperative nausea and vomiting
Other Names:
|
|
Other: Control
1.5 mg/kg intravenous, intraoperative (20 min before end of the surgery)
|
For postoperative pain
Other Names:
For postoperative nausea and vomiting
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preventing of postoperative nausea and vomiting
Time Frame: First 24 hours postoperatively
|
Preventing of postoperative nausea and vomiting in postoperative care unit
|
First 24 hours postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Adnan Menderes University, Aydin Adnan Menderes University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 20, 2018
Primary Completion (Actual)
August 20, 2018
Study Completion (Actual)
August 21, 2018
Study Registration Dates
First Submitted
July 5, 2018
First Submitted That Met QC Criteria
July 5, 2018
First Posted (Actual)
July 17, 2018
Study Record Updates
Last Update Posted (Actual)
August 12, 2020
Last Update Submitted That Met QC Criteria
August 11, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/1081
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.