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

NCT04062591 | Completed Early Phase 1

• 1 other identifier: FMASU R 54/ 2018
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

piroxicam; VAS; fractures

Outcome Measures

Primary Outcomes (1)

• rescue dose of analgesic

  patients needed additional doses of rescue analgesic

  24 hours

Study Arms (2)

piroxicam

ACTIVE COMPARATOR

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

Drug: Piroxicam group

placebo

SHAM COMPARATOR

saline IM in the same dose of piroxicam

Drug: Placebo

Interventions

Piroxicam group DRUG

patients will receive 0.4 mg/kg piroxicam IM

Also known as: piroxicam

piroxicam

Placebo DRUG

saline IM in the same dose of piroxicam

placebo

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams U

Cairo, 11566, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative; Fractures, Bone

Interventions

Piroxicam

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Nahed Effat, professor

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Anesthesia

Study Record Dates

• First Submitted: August 17, 2019
• First Posted: August 20, 2019
• Study Start: August 16, 2019
• Primary Completion: April 30, 2022
• Study Completion: December 31, 2022
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 7 months
• Access Criteria: Data were analyzed using SPSS Statistics version 23 (IBM© Corp., Armonk, NY, USA). Normally distributed numerical data were presented as mean and SD, and skewed data were presented as median and interquartile range. Qualitative data were presented as number and percentage or ratio. Normally distributed numerical data were compared using the unpaired t-test. Skewed numerical data were compared using the Mann-Whitney test and categorical data were compared using Fisher's exact test.

Locations

EG (1)