Comparing of the effects of intranasal administration of midazolam and dexmedetomidine premeditations in reducing anxiety and sedation of children candidates for inguinal hernia surgery

Comparing the efficacy of intranasal dexmedetomidine and midazolam as premedication for managing preoperative anxiety in children undergoing elective inguinal herniorrhaphy. Identify the optimal premedication to minimize anxiety and facilitate surgical preparation in pediatric patients.

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 trial on 70 patients. Blocking method will be used for randomization.

The aim of this randomized controlled trial is to compare the sedative and anxiolytic effects of intranasal dexmedetomidine versus midazolam in children aged 2-10 years (ASA physical status I or II) undergoing elective inguinal hernia surgery at Akbar Pediatric Hospital, Mashhad. Children in the intervention group will receive intranasal dexmedetomidine 1 mcg/kg, while those in the control group will receive intranasal midazolam 0.2 mg/kg, 30 minutes prior to induction of anesthesia. Both patients and researchers will be blinded to group allocation. Sedation and anxiety scores will be recorded every 5 minutes from the start of drug administration until 30 minutes post-administration, after which the child will be transferred to the operating room (OR)."

Inclusion Criteria: Children aged 2-10 years, with ASA physical status I or II, scheduled for elective inguinal hernia surgery. Exclusion Criteria: Children who refuse to participate, have allergies to study medications, any psychiatric disorders, upper respiratory tract infections, nasal pathologies causing nasal obstruction, neurological disorders, or a heart rate less than 80 beats per minute at baseline.

Intervention group : Intranasal dexmedetomidine 1 microgram per kilogram Control group: Intranasal Midazolam 0.2 milligram per kilogram

Anxiety Score; Sedation Score

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.

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