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The effect of intravenous paracetamol and ketorolac on acute pain, nausea, and vomiting in patients undergoing maxillofacial surgery.

Comparison of the Effect of Intravenous Paracetamol and Ketorolac on the Post – Operative Acute Pain, Nausea, and Vomiting after Maxillofacial Surgeries: A Double-Blind Randomized Clinical Trial" Randomized Clinical Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20110413006186N14
Enrollment
32
Registered
2024-12-18
Start date
2024-12-21
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Maxillofacial surgery. Fracture of malar, maxillary and zygoma bones

Interventions

Intervention 1: Intervention group: Patients who are candidates for maxillofacial surgery (ASA Class I, II) will first have an intravenous line with Anzioket No. 16 after entering the operating room.

Sponsors

Rasht University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients who are candidates for maxillofacial surgery under general anesthesia Patients between the ages of 18 and 60 Ability to communicate Obtaining written consent from patients

Exclusion criteria

Exclusion criteria: Unwillingness to participate in the study of patients undergoing maxillofacial surgery Previous history of allergy to nonsteroidal anti-inflammatory drugs and paracetamol, history of asthma, ischemic heart disease, renal and hepatic failure and unwillingness to participate in the study History of allergy to anesthetic drugs used in the study as well as allergy to morphine, paracetamol and ketorolac History of chronic use of narcotics and painkillers Pregnant women

Design outcomes

Primary

MeasureTime frame
Changes in pain intensity after maxillofacial surgery. Timepoint: In the recovery unit at 15 and 30 minute intervals, after transfer to the ward at 1, 2, 4 and 6 hours after surgery. Method of measurement: The primary outcome measure for this study is the Visual Analogue Scale . Patients are asked to indicate the intensity of their pain on a 10 cm ruler. Zero on the ruler indicates complete absence of pain, 5 indicates moderate pain, and 10 indicates the maximum pain experienced. All patients will be instructed on how to indicate pain on the ruler before surgery.

Secondary

MeasureTime frame
Changes in the incidence of nausea and vomiting. Timepoint: In the recovery unit at 15 and 30 minute intervals- After transfer to the ward at 1, 2, 4 and 6 hours after surgery. Method of measurement: The incidence of nausea and vomiting will be measured based on the frequency listed on the checklist.;Hypotension. Timepoint: In the recovery unit at 15 and 30 minute intervals-After transfer to the ward at 1, 2, 4 and 6 hours after surgery. Method of measurement: Checking whether there is a decrease of more than 20% in systolic blood pressure using a blood pressure monitor.;Heart rate. Timepoint: In the recovery unit at 15 and 30 minute intervals- After transfer to the ward at 1, 2, 4 and 6 hours after surgery. Method of measurement: Checking whether there is an increase or decrease of more than 20% in heart rate using a heart rate monitoring device.;Slow breathing rate. Timepoint: In the recovery unit at 15 and 30 minute intervals - After transfer to the ward at 1, 2, 4 and 6 hours after surgery. Method of measurement: Respiratory rate decreases or does not decrease below 12 breaths per minute using a respiratory monitoring device.;Hives and rash. Timepoint: In the recovery unit at 15 and 30 minute intervals - After transfer to the ward at 1, 2, 4 and 6 hours after surgery. Method of measurement: As a have or not, which will be included in the checklist.;Drowsiness. Timepoint: In the recovery unit at 15 and 30 minute intervals - After transfer to the ward at 1, 2, 4 and 6 hours after surgery. Method of measurement: As a have or not, which will be included in the checklist.;Feeling short of breath. Timepoint: In the recovery unit at 15 and 30 minute intervals - After transfer to the ward at 1, 2, 4 and 6 hours after surgery. Method of measurement: As a have or not, which will be included in the checklist.;Receive morphine painkiller. Timepoint: In the recovery unit at 15 and 30 minute intervals- After transfer to the ward at 1, 2, 4 and 6 hours after surgery. Method of

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Bahram Naderi Nabi

Rasht University of Medical Sciences

bnaderinabi@gmail.com+98 13 3332 9524

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026