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IRCT20220819055746N1 IRCT 2022-08-29 Tabriz University of Medical Sciences The effect of dexmedetomidine in reducing pain after jaw surgery Comparison of opioid requirement and pain intensity after mandibular surgeries in intraoperative infusion and bolus injection during dexmedetomidine extubation: a randomized clinical trial 2022-08-20 anticipated 40 Complete https://irct.ir/trial/65367 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random sampling will be done among the patients referred to the maxillofacial surgery department of Imam Reza Hospital in Tabriz who are eligible for the study. The randomization method is simple and its unit is individual. Random numbers are our tool for randomizing. Based on this, the type of treatment is marked with code A (infusion) and B (bolus) and placed inside sealed envelopes. Then the envelopes are placed in a bag and mixed. Then it is randomly selected from the bag and treatment is given to the patient by observing the code. None of the patients will be informed about the treatment of another patient, Blinding description: This study is double-blind. The injection will be done by an anesthesiologist. The researcher who will conduct the evaluation will not know about the type of intervention performed. Also, the person analyzing the data will be unaware of the type of intervention. N/A Fracture of mandible. Intervention 1: Intervention group: After surgery and before extubation, 5.0 mg/kg of dexmedetomidine will be infused. VAS will be measured. Also, the number of times needed for opioid medication will be recorded if the pain intensity of the patients is higher than 5. Intervention 2: Intervention group: After surgery and before extubation, 5.0 mg/kg dexmedetomidine will be injected by bolus method. Pain intensity during recovery, first, second, fourth, sixth, twelfth, and twenty-fourth hours after discharge from Recovery will be measured using VAS. Also, the number of times needed for opioid medication will be recorded if the pain intensity of the patients is higher than 5. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Saeed Nezafati
Golgasht St., Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 5166614711 +98 44 3344 4598 nezaf2000@yahoo.com Tabriz University of Medical Sciences scientific Saeed Nezafati
Golgasht St., Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 5166614711 +98 44 3344 4598 nezaf2000@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Age above 18 years Candidate for mandibular surgery Consent to participate in the study 18 years no limit Both History of allergy to dexmedetomidine Multi-trauma patients Addiction to drugs and psychoactive substances History of taking antidepressants History of previous mandible, maxilla and cheek surgery during the last three months Patients diagnosed with rheumatoid arthritis Patients with kidney and liver diseases Dialysis patients Patients receiving anticoagulant drugs Patients with a history of systemic infections Patients with hemostatic disorders S02.6 Fracture of mandible Treatment - Drugs Treatment - Drugs Intervention group: After surgery and before extubation, 5.0 mg/kg of dexmedetomidine will be infused. VAS will be measured. Also, the number of times needed for opioid medication will be recorded if the pain intensity of the patients is higher than 5. Intervention group: After surgery and before extubation, 5.0 mg/kg dexmedetomidine will be injected by bolus method. Pain intensity during recovery, first, second, fourth, sixth, twelfth, and twenty-fourth hours after discharge from Recovery will be measured using VAS. Also, the number of times needed for opioid medication will be recorded if the pain intensity of the patients is higher than 5. Pain intensity. Timepoint: during recovery, the first, second, fourth, sixth, twelfth and twenty-fourth hours after discharge from recovery. Method of measurement: Visual Analogue Scale. The amount of using opioid. Timepoint: during recovery, the first, second, fourth, sixth, twelfth and twenty-fourth hours after discharge from recovery. Method of measurement: The amount of pain during recovery is measured in the first, second, fourth, sixth, twelfth and twenty-fourth hours after discharge from recovery. If the Visual Analogue Scale is higher than 5, pethidine (Exir-Iran company) at the rate of 1 mg/kg will be injected intramuscularly. After four hours, in case of recurrence of pain, the pethidine injection will be repeated at the rate of 1mg/kg. The number of times the patient needs pethidine in twenty-four hours will be recorded. Tabriz University of Medical Sciences Approved 2022-06-27 Ethics committee of Tabriz University of Medical Sciences Golgasht St., Tabriz University of Medical Sciences Tabriz East Azarbaijan Iran (Islamic Republic of)