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 |
| Secondary identifying numbers | N0012128200 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 18/05/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M R J Sury
Scientific
Scientific
Anaesthetics
Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JH
United Kingdom
| Phone | +44 (0)20 7405 9200 ext 5399 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | melatonin |
| Primary outcome measure | Time taken to fall asleep for scanning |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/06/2003 |
| Completion date | 30/09/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Anaesthetics
London
WC1N 3JH
United Kingdom
WC1N 3JH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Great Ormond Street Hospital for Children NHS Trust/Institute of Child Health (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2006 | Yes | No |
