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 |
| Protocol serial number | N0206102394 |
| Sponsor | Department of Health (UK) |
| Funder | Royal Liverpool Children's NHS Trust (UK) |
- 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
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 |
|---|---|
| abc@email.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-blinded double dummy randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A blinded randomised controlled trial to assess rapidity, effectiveness, acceptability and safety with intranasal diamorphine compared to oral morphine of analgesia |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Signs and Symptoms: Pain |
| Intervention | Intranasal diamorphine vs oral morphine |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Diamorphine, morphine |
| Primary outcome measure(s) |
Time to onset of analgesia and efficacy of analgesia. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/03/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 16 Years |
| Sex | All |
| Target sample size at registration | 300 |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/03/2002 |
| Date of final enrolment | 31/03/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Royal Liverpool Children's Hospital NHS Trust
Liverpool
L12 2AP
United Kingdom
L12 2AP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
