]>
IRCT20240713062419N1 IRCT 2024-11-28 Mashhad University of Medical Sciences Comparing the effects of intranasal administration of midazolam and dexmedetomidine As premedication in reducing anxiety and sedation in children Comparing of the effects of intranasal administration of midazolam and dexmedetomidine premeditations in reducing anxiety and sedation of children candidates for inguinal hernia surgery 2024-09-22 anticipated 70 Complete https://irct.ir/trial/78528 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization was employed to allocate participants randomly. Block sizes of 4, 6, and 8 were selected for this study. A total of 12 blocks were created, comprising 4 blocks of size 4, 5 blocks of size 6, and 3 blocks of size 8. Each block contained a random sequence of participants assigned to either study arm. These blocks were sealed in opaque envelopes and randomized. For each eligible participant, a block was randomly selected, and the participant was assigned to the corresponding study arm based on the sequence within that block. This process continued until all blocks were exhausted and all participants were allocated, Blinding description: Participant: Parents provided informed consent for their child to be randomly assigned to either the intervention or control group. Researcher: The researcher was blinded to group allocation until after randomization to minimize bias. Assessor: The assessor was blinded to treatment allocation. 3 Condition 1: Hernia Surgery. Condition 2: Inguinal Hernia. Intervention 1: Intervention group: Intranasal dexmedetomidine 1 microgram per kilogram. Intervention 2: Control group: Intranasal Midazolam 0.2 milligram per kilogram. 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 Alireza Sabzevari
No.14, Shahid Kaveh Blvd.
Mashhad Iran (Islamic Republic of) 9177897157 +98 51 3871 3801 SabzevariA@mums.ac.ir Mashhad University of Medical Sciences scientific Alireza Sabzevari
.14, Shahid Kaveh Blvd.
Mahhad Iran (Islamic Republic of) 9177897157 +98 51 3871 3801 Sabzevaria@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Children aged 2 to 10 Candidate for Inguinal Hernia surgery American Society of Anesthesiologists (ASA) Classification of Patient's I and II class 2 years 10 years Both Dissatisfaction Allergy to drugs used for study Nasal Pathologies (like tumors, polyps, epistaxis,...) Upper respiratory tract infections Any mental disorder Any Neurologic disorder Heart Rate below 80 K40.9 K40.2 Unilateral inguinal hernia, without obstruction or gangrene Bilateral inguinal hernia, without obstruction or gangrene Treatment - Drugs Treatment - Drugs Intervention group: Intranasal dexmedetomidine 1 microgram per kilogram Control group: Intranasal Midazolam 0.2 milligram per kilogram Anxiety Score. Timepoint: At the time of drug administration and then every 5 minutes until 30 minutes. Method of measurement: Anxiety Score based on Akin et al Anxiety Score. Sedation Score. Timepoint: At the time of drug administration and then every 5 minutes until 30 minutes. Method of measurement: Sedation Score by using Modified Observers Assessment of Alertness/Sedation Scale (MOAA/S). Mashhad University of Medical Sciences Approved 2024-07-01 Research Ethics Committees of Imam Reza Hospital Educational, Research and Treatment Center- Mashhad Danesh va salamat town - Fakkoori blvd. Mashhad Razavi Khorasan Iran (Islamic Republic of)