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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016021826630N1

Enrollment

272

Registered

2016-03-04

Start date

2015-02-20

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

Condition 1: Traumatic subdural haemorrhage. Condition 2: Epidural haemorrhage. Condition 3: Traumatic subarachnoid haemorrhage. Traumatic subdural haemorrhage Epidural haemorrhage Traumatic subarachnoid haemorrhage

Interventions

Intervention 1: Control group: 1.5 mg per kilogram intravenous ketamine. Intervention 2: Case group: 4 milligram per kilogram of body weight intramuscular ketamine.

Case group: 4 milligram per kilogram of body weight intramuscular ketamine

Control group: 1.5 mg per kilogram intravenous ketamine

Eligibility

Sex/Gender

All

Age

1 Years to 6 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Arash Forouzan

Ahvaz Jundishapur University of Medical Sciences

arash-forouzan@ajums.ac.ir+98 61 3374 3079

Outcome results

None listed

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