Ain Shams U
Cairo, 11566, Egypt
NCT Number: NCT04062591
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.
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Notify Me16 year–25 year
All sexes
Interventional
Early Phase 1
Cairo, 11566, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
patients will receive 0.4 mg/kg piroxicam IM
Other names: piroxicam
saline IM in the same dose of piroxicam
Time frame: 24 hours
patients needed additional doses of rescue analgesic
Ain Shams University
Other
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