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Comparison of the sedative effect of intranasal midazolam and dexmedetomidine for pediatric

Comparison the sedative effect of intranasal midazolam and dexmedetomidine with for sedation of children1 to 6 year-old undergoing Computerized tomography(CT) scan that referred to emergency department of Kashani and Al-zahra hospitals in Isfahan in 2017

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190509043538N1
Enrollment
162
Registered
2019-08-26
Start date
2017-10-23
Completion date
Unknown
Last updated
2019-10-07

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

Conditions

Head trauma.

Interventions

Intervention 1: Intervention group: The intervention group will have received Dexmedetomidine (manufactured by Hospira Co. USA) interanasally. The agent will be prepared daily by a nurse and will pres

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 6 Years

Inclusion criteria

Inclusion criteria: Children's age range from 1 year to 6 years old requires a CT scan. Parental satisfaction to participate in this study.

Exclusion criteria

Exclusion criteria: Having excessive sensitivity to benzodiazepines and family members as well as alpha agonists Alertness level based on the Glasgow Coma Score less than 15 Having very low blood pressure or shock Having weak and unstable vital signs Having lung disease

Design outcomes

Primary

MeasureTime frame
Success in sedation intranasally. Timepoint: 0,10,20,30 min. Method of measurement: By Ramsay scoring.

Secondary

MeasureTime frame
Measurement of blood pressure ; pulse rate; blood oxygen saturation;. Timepoint: 0;10;20;30 minutes. Method of measurement: PulseOxymetery;Sphygmomanometer.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAzizkhani ,Reza

Esfahan University of Medical Sciences

r_azizkhani@med.mui.ac.ir+98 31 3620 2020

Outcome results

None listed

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