Efficacy of Piroxicam as a Perioperative Analgesic for Patients Undergoing Fixation of Maxillofacial Fractures

Early Phase 1

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Piroxicam group; Drug: Placebo

• Registration Number: NCT04062591
• Lead Sponsor: Ain Shams University

Brief Summary

At Eldemerdash Hospital at Ain Shams University in Egypt, 72 adult patients (16 to 25 years old) who had mandibular or maxillary fractures were treated with open reduction and internal stabilization. Patients were divided into two categories. (31 patients each) Using randomly generated data from computer, the piroxicam group received 0.4 mg/kg of intramuscular piroxicam, while the general anesthesia group (GA group) did not receive piroxicam.

The overall amount of rescue analgesic dosage and postoperative complications like nausea and vomiting were therefore included in the outcomes measurement.

Detailed Description

Patients were divided into two groups at random using a computer-generated list: the GA group received no piroxicam and the piroxicam group got a 0.4 mg/kg IM piroxicam induction. Both groups got IV paracetamol (24 mg/kg slowly administered over 20 minutes).

Fentanyl 2 micrograms/kg was administered after general anesthesia was induced and venous access was established. A suitable size endotracheal tube was then placed intranasal, and intubation was aided by Atracurium (0.5 mg/kg). Throughout the operation, 1 MAC isoflurane in a mixture of 50% air and oxygen was used to maintain anesthesia in all patients who were mechanically ventilated in pressure-controlled mode with targeted EtCO2 (30-35 mmHg). An oral pack was also introduced.

After the operation general anesthesia was stopped and the endotracheal tube was removed, Neostigmine 50 mg/kg and atropine sulfate 15 mg/kg were used to reverse muscle relaxation. Patient transportation was made to the post-anesthesia care unit (PACU). Postoperative analgesia was evaluated by a blind investigator using 10 cm- visual analogue scale score which had been explained to the patient on the preoperative visit where: 0 = no pain, 10 = worst possible pain) in the PACU then at 3, 6, 12, 24 hours, if the pain score \>3, pethidine 25 mg intravenously and Ondansetron 0.1mg/kg was used for cases with nausea or vomiting.

Study Timeline

• Study Start: 2019-08-16
• Study First Submitted: 2019-08-17
• Study First Submitted QC: 2019-08-19
• Study First Posted: 2019-08-20
• Primary Completion: 2022-04-30
• Study Completion: 2022-12-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-17
• Last Update Posted: 2023-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• patients aged from 16-25 years old
• ASAI II
• scheduled for open reduction and internal fixation of mandibular or maxillary fractures

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Exclusion Criteria

• a history of convulsion,
• gastrodudenal ulcer
• hematological disorders
• patient suffering from hepatic or renal dysfunction
• concomitant use of anticoagulants
• refusal of the patients to participate
• patients younger than 12 years

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
piroxicam	Piroxicam group	piroxicam group who received induction with piroxicam(0.4mg/kg) IM
placebo	Placebo	saline IM in the same dose of piroxicam

Primary Outcome Measures

Name	Time	Method
rescue dose of analgesic	24 hours	patients needed additional doses of rescue analgesic

Trial Locations

Locations (1)

Ain Shams U; 🇪🇬 Cairo, Egypt