Clinical trial NCT02299232: Dexmedetomidine in Children for Magnetic Resonance Imaging (MRI) Sedation
Official title: Comparison of Two Different Intranasal Doses of Dexmedetomidine in Children for Magnetic Resonance Imaging (MRI) Sedation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Keywords: dexmedetomidine
sedation
MRI
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Sixty patients aged between 1-10 years, American Society of Anesthesia (ASA) physical status I-II scheduled for MRI were allocated in this randomized double-blinded study. Group 1 received 3 mcg/kg, Group 2 received 4 mcg/kg intranasal dexmedetomidine before imaging. From the beginning on every 10 minutes heart rate (HR), saturation (SpO2) and Ramsey Sedation Score (RSS) were recorded. Induction time was time interval to receive RSS 5. MRI began and separation-score was noted. If intranasal sedation failed, an intravenous canula was placed and propofol was applied. Imaging quality was evaluated. Recovery time was time interval to receive Aldrete-score 9. Parents' satisfaction was questioned before patient was discharged.

Detailed description: OBJECTIVES OF STUDY Anesthetic agents used for MRI in paediatrics should have few adverse effects, allow fast induction and recovery. The administration route is also important and should be minimally invasive. In this study the investigators aimed to compare two different doses of intranasal dexmedetomidine applied to children for MRI sedation.

MATERIALS AND METHODS Sixty patients aged between 1-10 years, ASA I-II scheduled for MRI were allocated in this randomized double-blinded study. Group 1 received 3 mcg/kg, Group 2 received 4 mcg/kg intranasal dexmedetomidine before imaging. From the beginning on every 10 minutes HR, SpO2 and RSS were recorded. Induction time was time interval to receive RSS 5. MRI began and separation-score was noted. If intranasal sedation failed, an intravenous canula was placed and propofol was applied. Imaging quality was evaluated. Recovery time was time interval to receive Aldrete-score 9. Parents' satisfaction was questioned before patient was discharged.

Eligibility criteria: Inclusion Criteria:

* MRI
* ASA I-II

Exclusion Criteria:

* hepatic and renal failure
* difficult airway
* nasal deformity
* anaphylaxis to dexmedetomidine
* neurologic disease
* metabolic disorders
* electrolyte imbalance
* dehydration
* malnutrition

Primary outcomes:
measure: Ramsey Sedation Score
timeFrame: every 10 minutes for a two hours period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sisli Hamidiye Etfal Training and Research Hospital
name: Hacer Sebnem Turk, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ambi US, Joshi C, Ganeshnavar A, Adarsh E. Intranasal dexmedetomidine for paediatric sedation for diagnostic magnetic resonance imaging studies. Indian J Anaesth. 2012 Nov;56(6):587-8. doi: 10.4103/0019-5049.104588. No abstract available.
citation: Gyanesh P, Haldar R, Srivastava D, Agrawal PM, Tiwari AK, Singh PK. Comparison between intranasal dexmedetomidine and intranasal ketamine as premedication for procedural sedation in children undergoing MRI: a double-blind, randomized, placebo-controlled trial. J Anesth. 2014 Feb;28(1):12-8. doi: 10.1007/s00540-013-1657-x. Epub 2013 Jun 26.
citation: Tug A, Hanci A, Turk HS, Aybey F, Isil CT, Sayin P, Oba S. Comparison of Two Different Intranasal Doses of Dexmedetomidine in Children for Magnetic Resonance Imaging Sedation. Paediatr Drugs. 2015 Dec;17(6):479-85. doi: 10.1007/s40272-015-0145-1.