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IRCT20190929044924N1 IRCT 2019-11-10 Iran University of Medical Sciences Effect of tramadol as an adjuvant to ropivacaine in pediatric caudal epidural block Efficacyof tramadol as an adjuvant to ropivacaine in pediatric caudal epidural block 2018-11-22 anticipated 46 Complete https://irct.ir/trial/42644 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: By using the randomize number table, the patients were divided into two equal groups (n=23), Blinding description: Both drugs are injectable and the injection site of both drugs in the patients' body is in the same area. Therefore, patients' parents are not aware of the type of drug. Also, the outcome evaluator is unaware of the random allocation. N/A pain control. Intervention 1: Intervention group: Patients in first group will receive ropivacaine 0.2% per body weight before extubation. Intervention 2: Intervention group: Patients in second group will receive ropivacaine 0.2% per body weight with tramadol 2 mg/kg before extubation. No - There is not a plan to make this available Justification or reason for not sharing IPD is We have not decided yet
public Reza Farahmandrad
Rasool Akram Hospital, Niyayesh Ave., Satarkhan
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2326 farahmandrad.r@iums.ac.ir Iran University of Medical Sciences scientific Reza Farahmand rad
Rasool Akram Hospital, Niyayesh Ave., Satarkhan
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2326 Farahmandrad.r@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) American Society of Anesthesiologists (ASA) class I and II Surgery duration 30 minutes to 2 hours No sensitivity to tramadol and rupivacaine 3 years 10 years Both Complicated surgeries (long or bleeding in need of transfusion) Parent do not consent for their child to participate G89.18 Other acute postprocedural pain Treatment - Drugs Treatment - Drugs Intervention group: Patients in first group will receive ropivacaine 0.2% per body weight before extubation. Intervention group: Patients in second group will receive ropivacaine 0.2% per body weight with tramadol 2 mg/kg before extubation. Pain severity. Timepoint: One, 2 and 6 hours after surgery. Method of measurement: Using Modified Children’s Hospital of Eastern Ontario Pain Scale. Iran University of Medical Sciences Approved 2018-10-23 Ethics Committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat high way Tehran Tehran Iran (Islamic Republic of)