An open-label study followed by a double-blind randomised comparison of the effect of sedation versus melatonin combined with sedation in children undergoing magnetic resonance imaging (MRI)

ISRCTN	ISRCTN13459412
DOI	https://doi.org/10.1186/ISRCTN13459412
Protocol serial number	N0012128200
Sponsor	Department of Health
Funder	Great Ormond Street Hospital for Children NHS Trust/Institute of Child Health (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr M R J Sury
Scientific

Anaesthetics
Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JH
United Kingdom

Phone	+44 (0)20 7405 9200 ext 5399

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	How effective is melatonin when combined with other sedatives for sedation of children for MRI?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Not Applicable: Magnetic resonance imaging (MRI)
Intervention	1. Melatonin and combined sedatives 2. Melatonin
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	melatonin
Primary outcome measure(s)	Time taken to fall asleep for scanning
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/09/2003

Participant type(s)	Patient
Age group	Child
Sex	Not Specified
Key inclusion criteria	Children undergoing MRI
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/06/2003
Date of final enrolment	30/09/2003

Anaesthetics

London
WC1N 3JH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2006		Yes	No