A blinded randomised controlled trial to assess rapidity, effectiveness, acceptability and safety with intranasal diamorphine compared to oral morphine of analgesia

ISRCTN ISRCTN34432067
DOI https://doi.org/10.1186/ISRCTN34432067
Secondary identifying numbers N0206102394
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
05/12/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr B Stewart
Scientific

A&E Department
Royal Liverpool Children's Hospital NHS Trust
Alder Hey Children's Hospital NHS Foundation Trust
Eaton Road
Liverpool
L12 2AP
United Kingdom

Phone +44 (0)151 252 5583
Email abc@email.com

Study information

Study designSingle-blinded double dummy randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA blinded randomised controlled trial to assess rapidity, effectiveness, acceptability and safety with intranasal diamorphine compared to oral morphine of analgesia
Study objectivesIn children aged between 4-16 years attending Accident and Emergency (A&E) with acute traumatic injury, is there an improvement in safety, speed of onset and efficacy of analgesia, and patient acceptability using intranasal diamorphine compared to Oramorph?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSigns and Symptoms: Pain
InterventionIntranasal diamorphine vs oral morphine
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Diamorphine, morphine
Primary outcome measureTime to onset of analgesia and efficacy of analgesia.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/03/2002
Completion date31/03/2005

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit4 Years
Upper age limit16 Years
SexBoth
Target number of participants150 subjects in each arm
Key inclusion criteria1. Children aged 4-16 years attending the Accident and Emergency (A&E) department
2. With an acute injury who do not need resuscitation
3. Who would normally be offered oral morphine for analgesia
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/03/2002
Date of final enrolment31/03/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Royal Liverpool Children's Hospital NHS Trust
Liverpool
L12 2AP
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Royal Liverpool Children's NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan