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comparison of oral promethazine plus oral midazolam and oral midazolam in children sedation

Efficacy of oral sedation with midazolam and promethazine compared with midazolam in children less than 7 years old undergoing CT-scan

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201202279148N1
Enrollment
46
Registered
2013-01-21
Start date
2011-09-21
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

sedation.

Interventions

Intervention 1: Intervention group: they will be recive syrup promethazine 1.25 mg/kg orally one hour before the CT scan is done. Then a dose of o.5mg/kg oral midazolam 20 minutes before CT (mixed w
Treatment - Drugs
Intervention group: they will be recive syrup promethazine 1.25 mg/kg orally one hour before the CT scan is done. Then a dose of o.5mg/kg oral midazolam 20 minutes before CT (mixed with fruit juice)
control group: they will be receive Sugar syrup 0.5 mg/kg orally one hour before the CT scan is done.Then a dose of o.5mg/kg oral midazolam 20 minutes before CT (mixed with fruit juice) is given.If

Sponsors

Ahwaz Jondishapur Univercity Of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 7 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: children aged less than 7 years who were scheduled for CT scan and are placed under sedation Exclusion criteria: history of allergy to the ingredients used - having neurological defects and vascular defects

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Onset and duration of sleep. Timepoint: Continuously until the onset of drug effects. Method of measurement: observe of the patient and determine the level of consciousness.

Secondary

MeasureTime frame
Heart rate - Respiratory rate - blood pressure - oxygen saturation of arterial bloo. Timepoint: Every 5 minutes from start to finish drug effects. Method of measurement: beats per minute - respiratory per minute - mm Hg - percent.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Hassan Barzegari

Ahwaz Jondishapur Univercity Of Medical Sciences

h_b1979@yahoo.com+98 61 1374 3079

Outcome results

None listed

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