Clinical trial

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

Name
FMASU R 54/ 2018
Description
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.
Trial arms
Trial start
2019-08-16
Estimated PCD
2022-04-30
Trial end
2022-12-31
Status
Completed
Phase
Early phase I
Treatment
Piroxicam group
patients will receive 0.4 mg/kg piroxicam IM
Arms:
piroxicam
Other names:
piroxicam
Placebo
saline IM in the same dose of piroxicam
Arms:
placebo
Size
72
Primary endpoint
rescue dose of analgesic
24 hours
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 72, 'type': 'ACTUAL'}}
Updated at
2023-03-21

1 organization

1 product

1 drug

1 indication

Product
Piroxicam