Condition category
Signs and Symptoms
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
05/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes