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Intranasal dexmedetomide versus oral midazolam premedication for postoperative negative behavior changes in children: A randomized controlled trial

Intranasal dexmedetomide versus oral midazolam premedication for postoperative negative behavior changes in children

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082238
Enrollment
Unknown
Registered
2024-03-25
Start date
2024-03-27
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

Postoperative negative behavior

Interventions

Dexmedetomidine group:Patients were premedicated with intranasal dexmedetomidine 2 µg/kg and oral syrup 0.25 mL/kg.
Midazolam group:Patients were premedicated with intranasal 0.9% saline 0.02 mL/kg and oral midazolam 0.5 mg/kg.
Control group:Patients were premedicated with intranasal 0.9% saline 0.02 mL/kg and oral syrup 0.25 mL/kg.

Sponsors

Fujian Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 5 Years

Inclusion criteria

Inclusion criteria: 1. ASA physical status I or II; 2. Aged 2-5 years; 3. Scheduled for elective tonsillectomy and (or) adenoidectomy.

Exclusion criteria

Exclusion criteria: 1. Parents refusing to allow their children to participate; 2. Intake of sedative or analgesic medication within 48 hours before surgery; 3. Developmental delay; 4. Psychosis; 5. Body mass index > 30 kg/m2; 6. Allergy to study drugs; 7. Major life changes 1 month before the operation, such as the divorce of parents, death of parents, moving to a new home, changing to a new kindergarten, etc.; 8. Any other conditions that precluded study inclusion.

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative negative behavior changes;

Secondary

MeasureTime frame
Incidence of emergence delirium;Parental satisfaction;Preoperative sedation level;Incidence of postoperative negative behavior changes;

Countries

China

Contacts

Public ContactYao Yusheng

Fujian Provincial Hospital

fjslyys@fjmu.edu.cn+86 135 5993 9629

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026