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Comparison of Dexmedetomidine and Midazolam in Children Undergoing Abdominal Mass Surgery

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250420065398N1
Enrollment
60
Registered
2026-05-07
Start date
2024-12-21
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric patients undergoing abdominal mass surgery. Restlessness and agitation

Interventions

Intervention 1: Intervention group: Patients in this group, after induction of standard general anesthesia including the use of sevoflurane (MAC=8%) and nitrous oxide (60%), and after achieving adequa

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
9 Months to No maximum

Inclusion criteria

Inclusion criteria: Children aged more than 9 months Candidates for elective abdominal mass surgery American Society of Anesthesiologists physical status I or II Both male and female patients Written informed consent obtained from parents or legal guardians

Exclusion criteria

Exclusion criteria: Known allergy or hypersensitivity to dexmedetomidine or midazolam Presence of significant cardiac, respiratory, hepatic, or renal disease Use of sedative or analgesic drugs within 24 hours before surgery

Design outcomes

Primary

MeasureTime frame
Emergence agitation severity. Timepoint: At recovery room arrival and during the first 30 minutes after extubation. Method of measurement: Assessed using the Emergence Agitation Scale.

Secondary

MeasureTime frame
Postoperative pain intensity. Timepoint: During the first 30 minutes after extubation. Method of measurement: Assessed using the Visual Analog Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Mehdi Saadatmand

Shahid Beheshti University of Medical Sciences

Mahdi.saadatmand@gmail.com+98 939 529 4299

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026