Contact information
Type
Scientific
Primary contact
Dr B Stewart
ORCID ID
Contact details
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
+44 (0)151 252 5583
abc@email.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0206102394
Study information
Scientific title
A blinded randomised controlled trial to assess rapidity, effectiveness, acceptability and safety with intranasal diamorphine compared to oral morphine of analgesia
Acronym
Study hypothesis
In 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
Not provided at time of registration
Study design
Single-blinded double dummy randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Signs and Symptoms: Pain
Intervention
Intranasal diamorphine vs oral morphine
Intervention type
Drug
Phase
Not Applicable
Drug names
Diamorphine, morphine
Primary outcome measures
Time to onset of analgesia and efficacy of analgesia.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/03/2002
Overall trial end date
31/03/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
150 subjects in each arm
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/03/2002
Recruitment end date
31/03/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Liverpool Children's Hospital NHS Trust
Liverpool
L12 2AP
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Royal Liverpool Children's NHS Trust (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