Oral midazolam versus intranasal Dexmedetomidine for CT imaging in children

Phase 3

Completed

• Conditions: Pediatric patients visiting hospital for diagnostic CT Imaging

• Registration Number: CTRI/2014/03/004456
• Lead Sponsor: Post Graduate Institute of Medical Education and Research

Brief Summary

**Infants and children frequently require sedation to prevent motion artifacts during radiological imaging. We compared intranasal dexmedetomidine premedication (2.5mcg/kg) with oral midazolam 0.5 mg/kg for sedation in children undergoing CT imaging. Children were randomized to one of the two groups Group M received 0.5 mg/Kg midazolam and group D received 2.5 mc/Kg intranasal dexmedetomidine. After 20-30 minutes IV line was placed. The child was then transferred to CT table for imaging. Wilton score were observed and noted at that time. According to the level of sedation and scan duration, the child received 0.5 –1mg/Kg I.V ketamine to achieve a level of deep sedation. Any movement, motion artifact or repeat scans reported by radiologist were noted.**

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-12
• Last Update Posted: 2014-06-03

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

ASA I or II children aged 1 – 5 years scheduled for CT imaging under sedation.

Exclusion Criteria

Children with history of allergy to eutectic mixture of local anesthetic (EMLA) cream, midazolam severe dysfunction of central nervous system, malformation of cardiovascular system, children on chronic hepatic enzyme inducing drugs or mentally retarded children.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of children requiring rescue sedation (IV ketamine)	during CT Imaging

Secondary Outcome Measures

Name	Time	Method
incidence of children crying at venipuncture, number of attempts at venipuncture, sedation and venipuncture scores, requirement of ketamine for CT, parental satisfaction, movements and motion artifacts during scan and requirement of repeat scan	at venepuncture and during CT imaging

Trial Locations

Locations (1)

Post Graduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, CHANDIGARH, India

Post Graduate Institute of Medical Education and Research

🇮🇳Chandigarh, CHANDIGARH, India

Dr Babita Ghai

Principal investigator

09914209533

ghaibabita@hotmail.com