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IRCT20220312054261N1 IRCT 2022-04-03 Esfahan University of Medical Sciences effect of adding Dexamethasone and Dexmedetomidine to Bupivacaine infiltration Comparison of the effect of adding Dexamethasone and Dexmedetomidine to Bupivacaine infiltration on cleft lip surgery pain 2022-05-22 anticipated 75 Complete https://irct.ir/trial/62631 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The lottery is used for randomization and is adjusted based on the patients' national code number. The national number of patients is prepared and each number is written on a piece of paper, then drawn (one of the nurses in the study is asked to shuffle the sheets in a cup and one by one The first 25 people will be in the first group, the second 25 people will be in the second group and the rest of the patients will be in the third group, Blinding description: The method of blinding is double-blind. The main researcher prepares the drugs in the appropriate dose in a specific syringe and the surgeon injects the drug into the site of the cleft lip without knowing the content of the drug, and the person who records the parameters and Collects does not know the type of drugs. 3 the pain. Intervention 1: Intervention group: epinephrine 1200000, 1 cc bupivacaine 0.5% and 0.1 mg / kg dexamethasone with a total volume of 2 cc- Drops of dexamethasone ampoules 8 mg / 2 ml [Raha Pharmacy]- bupivacaine -agutant vial 0.5% 20 ml [Exir Pharmacy]. Intervention 2: Intervention group: epinephrine 1200000, 1 cc of bupivacaine 0.5% and 0.5 μg / kg of dexmedetomidine with a total volume of 2 cc - Madonex vial 200 micrograms / 2 ml [Exir Pharmacy]- Epinephrine DP 0.01% 10 ml ampoule[Drug Distributor - Factory]. Intervention 3: Intervention group: epinephrine 1200000, 1 cc of bupivacaine 0.5% to a total volume of 2 cc. 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 more information
public Sedighe Shahhosseini
Imam Khomeini street
Isfahan Iran (Islamic Republic of) 81746-73461 003133866266 nasrin20ir@gmail.com Esfahan University of Medical Sciences scientific Iman Reisi
Imam Khomeini street
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3128 5696 Iman.reeisy@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Age between 3 and 10 months Candidate of unilateral cleft lip of both sexes The first operation is lip cleft Duration of surgery less than 2 hours ASA patients have I and II Parents must complete the study entry consent form. 3 months 10 months Both The surgery lasts more than 2 hours Hemodynamic changes require therapeutic action Re-need for topical injection of epinephrine at the site of surgery Reaction to any of the drugs studied G89.29 Other chronic pain Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: epinephrine 1200000, 1 cc bupivacaine 0.5% and 0.1 mg / kg dexamethasone with a total volume of 2 cc- Drops of dexamethasone ampoules 8 mg / 2 ml [Raha Pharmacy]- bupivacaine -agutant vial 0.5% 20 ml [Exir Pharmacy] Intervention group: epinephrine 1200000, 1 cc of bupivacaine 0.5% and 0.5 μg / kg of dexmedetomidine with a total volume of 2 cc - Madonex vial 200 micrograms / 2 ml [Exir Pharmacy]- Epinephrine DP 0.01% 10 ml ampoule[Drug Distributor - Factory] Intervention group: epinephrine 1200000, 1 cc of bupivacaine 0.5% to a total volume of 2 cc Need to Tranquilizer. Timepoint: Preoperative, postoperative, 24 hours postoperative. Method of measurement: Using the scale of face, legs, activity, crying and comfort, which is one of the most common and widely used scales of observational-behavioral pain. Esfahan University of Medical Sciences Approved 2022-03-05 Ethics committee of Isfahan University of Medical Sciences Hezar Jerib Street, Shiraz Gate Square Isfahan Isfehan Iran (Islamic Republic of)