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
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring piroxicam, VAS, fractures
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
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
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.
Learn more about this trial
Efficacy of Piroxicam as a Perioperative Analgesic for Patients Undergoing Fixation of Maxillofacial Fractures
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