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

NCT ID: NCT04062591

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-16
• Study Completion Date: 2022-12-31

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

piroxicam

piroxicam group who received induction with piroxicam(0.4mg/kg) IM

Group Type: ACTIVE_COMPARATOR

Piroxicam group

Intervention Type: DRUG

patients will receive 0.4 mg/kg piroxicam IM

placebo

saline IM in the same dose of piroxicam

Group Type: SHAM_COMPARATOR

Placebo

Intervention Type: DRUG

saline IM in the same dose of piroxicam

Interventions

Piroxicam group

patients will receive 0.4 mg/kg piroxicam IM

Intervention Type: DRUG

Placebo

saline IM in the same dose of piroxicam

Intervention Type: DRUG

Other Intervention Names

piroxicam

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Hoda Shokri

Associate professor of Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nahed Effat, professor

Role: STUDY_DIRECTOR

Ain Shams University

Locations

Ain Shams U

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FMASU R 54/ 2018

Identifier Type: -

Identifier Source: org_study_id