Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0012128200
Study information
Scientific title
Acronym
Study hypothesis
How effective is melatonin when combined with other sedatives for sedation of children for MRI?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Condition
Not Applicable: Magnetic resonance imaging (MRI)
Intervention
1. Melatonin and combined sedatives
2. Melatonin
Intervention type
Drug
Phase
Not Specified
Drug names
melatonin
Primary outcome measures
Time taken to fall asleep for scanning
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/06/2003
Overall trial end date
30/09/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Children undergoing MRI
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/06/2003
Recruitment end date
30/09/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Anaesthetics
London
WC1N 3JH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Great Ormond Street Hospital for Children NHS Trust/Institute of Child Health (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16782974
Publication citations
-
Results
Sury MR, Fairweather K, The effect of melatonin on sedation of children undergoing magnetic resonance imaging., Br J Anaesth, 2006, 97, 2, 220-225, doi: 10.1093/bja/ael144.