Comparison of efficiency of ketamine when injected into a blood vessel or injected in a muscle for providing a sleep state for children to undergo MRI scan.
- Conditions
- Encounter for screening for otherspecified diseases and disorders,
- Registration Number
- CTRI/2021/05/033895
- Brief Summary
Pediatric patients coming for MRI scan for various complaints who fullfil the inclusion criteria will be enrolled for study. Intravenous and intramuscular route for giving ketamine sedation is equally used in our institute. 108 patients will be enrolled. 54 in each group. The assignment of the patient to the IV or IM ketamine group will depend on the personal preference of the anaesthesiologist faculty incharge on that day. The doses of ketamine is 1 mg/kg and 4 mg/kg in IV and IM group respectively. In case of inadequate sedation within 10 mins half of loading dose of ketamine will be repeated. Patients will undergo MRI scan after adequately sedated. Rescue doses of propofol 0.5mg/kg will be used in case of inadequate sedation during the scan. Sedation efficacy of IV and IM will be assesed based on the time required to achieve adequate sedation to start MRI scan, number of rescue doses of propofol required to complete the scan and number of MRI sequences repeated due to inadequate sedation. Patients will be monitored for any adverse events during and after scan. Recovery time will be monitored using Modified Aldrete score of equal to or more than 9.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 108
- Patients of either gender of age group 2 to 8 year.
- American society of anaesthesiologists physical status (ASA) I and II patients.
- Patients with anticipated difficult airway.
- Raised Intracranial or intraocular pressure.
- Vascular aneurysms.
- History of adverse reaction to ketamine or any other drug used in the study Active seizures.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intravascular and Intramuscular route of ketamine administration are almost equally popular in MRI sedation. However, the use of ketamine in sedation for MRI is highly skewed in favour of intravascular. The two routes have never been compared for sedation in MRI. 0-6th month – Collection of data and literature review. | 6th -7th – statistical calculations will be done and result will be provided. The sedative efficacy and safety profile and time to discharge in intravenous and intramuscular ketamine are not significantly different. IM method might lead to lesser need of rescue doses. 0-6th month – Collection of data and literature review. | 6th -7th – statistical calculations will be done and result will be provided.
- Secondary Outcome Measures
Name Time Method To compare any adverse events like bradycardia, hypotension, desaturation, laryngospasm, apnea, excessive salivation, vomiting, emergence delirium, excessive drowsiness, involuntary movements, seizure occurring during the MRI scanning or in the recovery period. To compare the time required for recovery to achieve Modified Andree score equal to 9 or more.
Trial Locations
- Locations (1)
All India Institute of Medical Sciences Bhopal
🇮🇳Bhopal, MADHYA PRADESH, India
All India Institute of Medical Sciences Bhopal🇮🇳Bhopal, MADHYA PRADESH, IndiaDr Anuj JainPrincipal investigator9755702644anuj.jain.mln@gmail.com