Comparison Between Efficacy and Side Effects of Intravenous and Intramuscular Ketamine for Sedation of 1 to 6 Years Old Childre

Phase 3

• Conditions: Condition 1: Traumatic subdural haemorrhage. Condition 2: Epidural haemorrhage. Condition 3: Traumatic subarachnoid haemorrhage.; Traumatic subdural haemorrhage; Epidural haemorrhage; Traumatic subarachnoid haemorrhage

• Registration Number: IRCT2016021826630N1
• Lead Sponsor: Vice challencor for reasearch of Ahvaz Jundishapur University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 272

Inclusion Criteria

need for sedation to imaging; age below 6 years old Exclusion criteria: history of hypersensitivity to ketamine; evidences of abnormal brain; evidence of rise of intracranial pressure; history of apnea and respiratory disorders; history of severe traumatic brain injury; no sedation with standard dose; parental disagreement

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to start sedation. Timepoint: immediately after infusion of drug. Method of measurement: minutes.;Grade of sedation. Timepoint: 1 minute after infusion, 5 minutes after infusion, 15 minutes after infusion. Method of measurement: Ramsay Sedation Scale.

Secondary Outcome Measures

Name	Time	Method
Vomiting. Timepoint: Up to one hour after infusion of drug. Method of measurement: Observation.;Apnea. Timepoint: Up to 15 minutes after infusion of drug. Method of measurement: Observation.;Seizure. Timepoint: Up to 15 minutes after infusion of drug. Method of measurement: Observation.