Comparison of the Effects of Dexmedetomidine and Midazolam on Postoperative Pain and Agitation in Pediatric Patients Undergoing Abdominal Mass Surgery

Comparison of the Effects of Dexmedetomidine and Midazolam on Postoperative Pain and Agitation in Pediatric Patients Undergoing Abdominal Mass Surgery.

A randomized, double-blind, parallel-group clinical trial with 30 participants per group. Randomization was performed using a random number table.

Children who are candidates for elective abdominal mass surgery and who refer to Mofid Children’s Hospital in Tehran during the study will, if eligible, enter the study and will be randomly allocated to two groups. The drugs are administered by the responsible nurse, in equal volumes and without identifying labels. This study is conducted in a double‑blind manner, such that the patients, the treating physician, and the outcome assessor are unaware of the type of intervention.

Inclusion criteria: Children older than 9 months and candidates for elective surgery of abdominal masses, physical status I or II according to ASA (American Society of Anesthesiologists), both sexes, and with parental informed consent. Exclusion criteria: Hypersensitivity to dexmedetomidine or midazolam, significant cardiac, respiratory, hepatic or renal disease, and use of sedative or analgesic medication within 24 hours before surgery.

Standard induction of anesthesia is performed for all patients and before extubation: dexmedetomidine group (Exir company): 4 micrograms per kilogram dexmedetomidine diluted with 5% dextrose to a volume of 5 milliliters, and midazolam group (Exir company): 0.5 milligrams per kilogram midazolam diluted with the same volume of dextrose. The solution is given to the nurse without a label and administered intranasally to the patient.

Emergence agitation;Postoperative pain

Eligible patients will be randomly assigned to one of the two groups receiving dexmedetomidine or midazolam. Randomization will be performed using a simple randomization method and by means of a computer‑based random number table. The random allocation sequence will be performed using SPSS software. Group allocation will be concealed by sealed, opaque, and sequentially serial‑numbered envelopes that have been prepared by an individual independent of the study implementation team.

This study is designed as a double‑blind clinical trial.The study drugs will be prepared in equal volumes and administered intranasally by a nurse who is not involved in the evaluation of patients and data collection.The patients, their parents, clinical caregivers, and outcome assessors will be unaware of the group assignments throughout the study period.

De-identified individual participant data collected during the study

Not determined

Access, if any, will be limited to the research team and subject to institutional approval

Data may be used for academic and research purposes only, subject to ethical approval and data protection regulations

Requests should be directed to the principal investigator

Requests will be reviewed by the research team and evaluated based on ethical and institutional policies