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Paracetamol on Postoperative Nausea and Vomiting

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03588338
Enrollment
90
Registered
2018-07-17
Start date
2018-07-20
Completion date
2018-08-21
Last updated
2020-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Nausea and Vomiting

Keywords

PONV, Paracetamol

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.

Interventions

For postoperative pain

DRUGControl

For postoperative nausea and vomiting

Sponsors

Aydin Adnan Menderes University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Preventing of postoperative nausea and vomitingFirst 24 hours postoperativelyPreventing of postoperative nausea and vomiting in postoperative care unit

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026