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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Piroxicam group
Placebo
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring piroxicam, VAS, fractures

Eligibility Criteria

16 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ain Shams U

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

piroxicam

placebo

Arm Description

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

saline IM in the same dose of piroxicam

Outcomes

Primary Outcome Measures

rescue dose of analgesic
patients needed additional doses of rescue analgesic

Secondary Outcome Measures

Full Information

First Posted
August 17, 2019
Last Updated
March 17, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04062591
Brief Title
Efficacy of Piroxicam as a Perioperative Analgesic for Patients Undergoing Fixation of Maxillofacial Fractures
Official Title
Efficacy of Piroxicam as a Perioperative Analgesic for Patients Undergoing Fixation of Maxillofacial Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 16, 2019 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
piroxicam, VAS, fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
piroxicam
Arm Type
Active Comparator
Arm Description
piroxicam group who received induction with piroxicam(0.4mg/kg) IM
Arm Title
placebo
Arm Type
Sham Comparator
Arm Description
saline IM in the same dose of piroxicam
Intervention Type
Drug
Intervention Name(s)
Piroxicam group
Other Intervention Name(s)
piroxicam
Intervention Description
patients will receive 0.4 mg/kg piroxicam IM
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
saline IM in the same dose of piroxicam
Primary Outcome Measure Information:
Title
rescue dose of analgesic
Description
patients needed additional doses of rescue analgesic
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nahed Effat, professor
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
Ain Shams U
City
Cairo
ZIP/Postal Code
11566
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
study protocol statistical analysis data analysis
IPD Sharing Time Frame
7 months
IPD Sharing 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.

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

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