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

Overview

Patients were allocated randomly by a computer-generated list into two groups: piroxicam group who received induction with piroxicam(0.4mg/kg) IM and GA group where piroxicam was not given. Paracetamol IV (24 mg/kg given slowly over 20 minutes) was received by both groups. After general anesthesia was induced and venous access established, fentanyl 2 micrograms/kg was given and an appropriate size endotracheal tube was placed intranasal, intubation was facilitated by Atracurium (0.5 mg/kg). All patients were mechanically ventilated with pressure-controlled mode with targeted EtCO 2 (30-35 mmHg)and anaesthesia was maintained by 1 MAC Isoflurane in a mixture of 50% air and oxygen in all cases throughout the procedure and oral pack was introduced. At the end of the procedure,muscle relaxation was reversed by neostigmine 50 μg/kg and atropine sulfate 15μg/kg then the endotracheal tube was removed and general anesthesia was discontinued. Patients were taken to the post anesthesia care unit (PACU).

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: April 2020

Detailed Description

After approval of the medical ethical committee of Ain Shams University, Egypt and informed consent from the parents were obtained in all cases. 60 children, aged from 16-25 years, ASA physical status I or II, scheduled for open reduction and internal fixation of mandibular or maxillary fractures, were included in this study which was carried out between 2019-2020. The patients who had a history of convulsion, gastrodudenal ulcer, or hematological disorders, patient suffering from hepatic or renal dysfunction, concomitant use of anticoagulants, refusal of the patients to participate and patients younger than 12 years were excluded. No premedication was given. Intraoperative monitoring included, ECG, pulse oximetry, non-invasive blood pressure, and end tidal carbon dioxide concentration. Patients were allocated randomly by a computer-generated list into two groups: piroxicam group who received induction with piroxicam(0.4mg/kg) IM and GA group where piroxicam was not given. Paracetamol IV (24 mg/kg given slowly over 20 minutes) was received by both groups. After general anesthesia was induced and venous access established, fentanyl 2 micrograms/kg was given and an appropriate size endotracheal tube was placed intranasal, intubation was facilitated by Atracurium (0.5 mg/kg). All patients were mechanically ventilated with pressure-controlled mode with targeted EtCO 2 (30-35 mmHg)and anaesthesia was maintained by 1 MAC Isoflurane in a mixture of 50% air and oxygen in all cases throughout the procedure and oral pack was introduced. At the end of the procedure,muscle relaxation was reversed by neostigmine 50 μg/kg and atropine sulfate 15μg/kg then the endotracheal tube was removed and general anesthesia was discontinued. Patients were taken 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 The primary outcomes included total dose of rescue analgesic , and secondary outcomes included pain scores , time to first analgesic dose and postoperative complications as vomiting.Ondansetron 0.1mg/kg was used for cases with nausea or vomiting.

Interventions

  • Drug: Piroxicam group
    • patients will receive 0.4 mg/kg piroxicam IM
  • Drug: Placebo
    • saline IM in the same dose of piroxicam

Arms, Groups and Cohorts

  • Active Comparator: piroxicam
    • piroxicam group who received induction with piroxicam(0.4mg/kg) IM
  • Sham Comparator: placebo
    • saline IM in the same dose of piroxicam

Clinical Trial Outcome Measures

Primary Measures

  • rescue dose of analgesic
    • Time Frame: 24 hours
    • patients needed additional doses of rescue analgesic

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 25 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ain Shams University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hoda Shokri, Associate professor of Anesthesia – Ain Shams University
  • Overall Official(s)
    • Nahed Effat, professor, Study Director, Ain Shams University
  • Overall Contact(s)
    • Hoda Shokri, 201211179234, drhoda10@yahoo.com

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