NCT03588338

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 17, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

July 20, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2018

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

1 month

First QC Date

July 5, 2018

Last Update Submit

August 11, 2020

Conditions

Postoperative Nausea and Vomiting

Keywords

PONVParacetamol

Outcome Measures

Primary Outcomes (1)

  • Preventing of postoperative nausea and vomiting

    Preventing of postoperative nausea and vomiting in postoperative care unit

    First 24 hours postoperatively

Study Arms (2)

Perfalgan

ACTIVE COMPARATOR

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

Drug: PerfalganDrug: Control

Control

OTHER

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

Drug: PerfalganDrug: Control

Interventions

PerfalganDRUG

For postoperative pain

Also known as: Paracetamol
ControlPerfalgan
ControlDRUG

For postoperative nausea and vomiting

Also known as: Saline
ControlPerfalgan

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ASA (the classification of the American Society of Anesthesiologists) physical status I-II
  • Patients who scheduled for elective maxillofacial surgery under general anesthesia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ozlem Kocaturk

Aydin, 09100, Turkey (Türkiye)

Location

Related 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.

    PMID: 21986980BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

AcetaminophenSodium Chloride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Adnan Menderes University

    Aydin Adnan Menderes University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty of Dentisty Oral and Maxillofacial Surgery

Study Record Dates

First Submitted

July 5, 2018

First Posted

July 17, 2018

Study Start

July 20, 2018

Primary Completion

August 20, 2018

Study Completion

August 21, 2018

Last Updated

August 12, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)