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Paracetamol on Postoperative Nausea and Vomiting

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Perfalgan
Control
Sponsored by
Aydin Adnan Menderes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring PONV, Paracetamol

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ozlem Kocaturk

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Perfalgan

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Preventing of postoperative nausea and vomiting
Preventing of postoperative nausea and vomiting in postoperative care unit

Secondary Outcome Measures

Full Information

First Posted
July 5, 2018
Last Updated
August 11, 2020
Sponsor
Aydin Adnan Menderes University
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1. Study Identification

Unique Protocol Identification Number
NCT03588338
Brief Title
Paracetamol on Postoperative Nausea and Vomiting
Official Title
The Effect of Paracetamol on Postoperative Nausea and Vomiting Following Maxillofacial Surgery: a Prospective, Randomised, Double-blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 20, 2018 (Actual)
Primary Completion Date
August 20, 2018 (Actual)
Study Completion Date
August 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aydin Adnan Menderes University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
PONV, Paracetamol

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Perfalgan
Arm Type
Active Comparator
Arm Description
1.5 mg/kg intravenous, intraoperative (20 min before end of the surgery)
Arm Title
Control
Arm Type
Other
Arm Description
1.5 mg/kg intravenous, intraoperative (20 min before end of the surgery)
Intervention Type
Drug
Intervention Name(s)
Perfalgan
Other Intervention Name(s)
Paracetamol
Intervention Description
For postoperative pain
Intervention Type
Drug
Intervention Name(s)
Control
Other Intervention Name(s)
Saline
Intervention Description
For postoperative nausea and vomiting
Primary Outcome Measure Information:
Title
Preventing of postoperative nausea and vomiting
Description
Preventing of postoperative nausea and vomiting in postoperative care unit
Time Frame
First 24 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adnan Menderes University
Organizational Affiliation
Aydin Adnan Menderes University
Official's Role
Study Director
Facility Information:
Facility Name
Ozlem Kocaturk
City
Aydin
ZIP/Postal Code
09100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21986980
Citation
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.
Results Reference
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Paracetamol on Postoperative Nausea and Vomiting

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