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Trial record 3 of 122 for:    Recruiting, Not yet recruiting, Available Studies | Nausea and vomiting

Paracetamol vs Metoclopramide on Postoperative Nausea and Vomiting

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ClinicalTrials.gov Identifier: NCT03588338
Recruitment Status : Not yet recruiting
First Posted : July 17, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Ozlem Kocaturk, Adnan Menderes University

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 and metoclopramide on PONV in adults undergoing maxillofacial surgery.

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Drug: Perfalgan Drug: Metoclopramide Phase 4

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 metoclopramide (0.2 mg/kg) in saline. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Comparison of Paracetamol and Metoclopramide on Postoperative Nausea and Vomiting Following Maxillofacial Surgery: a Prospective, Randomised, Double-blind Study
Estimated Study Start Date : July 20, 2018
Estimated Primary Completion Date : August 20, 2018
Estimated Study Completion Date : August 21, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Perfalgan
1.5 mg/kg intravenous, intraoperative (20 min before end of the surgery)
Drug: Perfalgan
For postoperative pain
Other Name: Paracetamol

Drug: Metoclopramide
For postoperative nausea and vomiting
Other Name: Metocloptamide hydrochloride

Active Comparator: Metoclopramide
0.2 mg/kg intravenous, intraoperative (20 min before end of the surgery)
Drug: Perfalgan
For postoperative pain
Other Name: Paracetamol

Drug: Metoclopramide
For postoperative nausea and vomiting
Other Name: Metocloptamide hydrochloride




Primary Outcome Measures :
  1. Preventing of postoperative nausea and vomiting [ Time Frame: First 24 hours postoperatively ]
    Preventing of postoperative nausea and vomiting in postoperative care unit



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03588338


Contacts
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Contact: Ozlem Kocaturk 905367730400 ozlemoget2002@yahoo.com
Contact: Tolga Kocaturk 905333444111 tolgakocaturk@gmail.com

Sponsors and Collaborators
Adnan Menderes University
Investigators
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Study Director: Adnan Menderes University Adnan Menderes University

Publications:
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Responsible Party: Ozlem Kocaturk, Faculty of Dentisty Oral and Maxillofacial Surgery, Adnan Menderes University
ClinicalTrials.gov Identifier: NCT03588338     History of Changes
Other Study ID Numbers: 2017/1081
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Ozlem Kocaturk, Adnan Menderes University:
PONV
Paracetamol

Additional relevant MeSH terms:
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Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Acetaminophen
Metoclopramide
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action