Condition category
Haematological Disorders
Date applied
04/03/2011
Date assigned
01/06/2011
Last edited
25/04/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Sickle cell anaemia is an inherited blood disorder which results in abnormal ‘sickle’ shaped red blood cells which do not fit well through small blood vessels, becoming trapped and forming blockages. Blockages prevent oxygen in the blood from reaching different parts of the body, resulting in pain. These painful crises occur commonly in children. These crises are unpredictable, affecting any area of the body, although the chest, tummy, and bones are frequently affected sites. Crises may be separated by more than a year or possibly only by weeks, and they can last from hours to weeks. Pain relief is first achieved with paracetamol or ibuprofen for milder painful episodes, but many may need stronger pain relief in the Emergency Department. Stronger pain relief may be achieved by oral medicine (codeine/morphine) and drip medicine (intravenous morphine) for moderate to severe episodes of pain. Fentanyl (another type of strong pain relief), delivered via the nose as a spray (intranasal), has been shown to be as safe and as good as morphine (via a drip) in children with broken bones or tummy pain, with the benefit of quicker time to start acting, as it does not rely on the placement of a drip. The procedure of receiving intranasal fentanyl is also less distressful for the child than a drip. The aim of this study is to assess the effect of intranasal fentanyl in painful sickle cell crisis to see whether it is as good as strong pain relief via a drip.

Who can participate?
Patients aged 1 to 21 with severe pain due to sickle cell disease

What does the study involve?
Participants are randomly allocated to be treated with either intranasal fentanyl or intravenous morphine. Pain, time to analgesic (pain relief) effect, need for more pain relief, side effects such as nausea and vomiting, breathing, heart rate and blood pressure are measured in both groups.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University College Dublin (Ireland)

When is the study starting and how long is it expected to run for?
September 2011 to June 2013

Who is funding the study?
National Children's Research Centre, Our Lady's Children's Hospital (Ireland)

Who is the main contact?
Prof. Ronan O'Sullivan
ronan.osullivan@olchc.ie

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ronan O'Sullivan

ORCID ID

Contact details

School of Medicine & Medical Science
University College Dublin
Our Lady's Children's Hospital Crumlin
Dublin
12
Ireland
+353 (0)1 409 6100/6324
ronan.osullivan@olchc.ie

Additional identifiers

EudraCT number

2011-005161-20

ClinicalTrials.gov number

Protocol/serial number

08051980

Study information

Scientific title

A randomised, controlled, double blind trial of intranasal fentanyl versus intravenous morphine in the paediatric emergency department in treatment of severe painful sickle cell crisis

Acronym

Study hypothesis

Those patients with severe painful sickle cell crisis receiving intransala (IN) fentanyl will achieve similar pain relief to those who receive intravenous (IV) morphine.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled double-blind trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the conatct details to request a patient information sheet

Condition

Painful sickle cell crisis

Intervention

Intranasal fentanyl or intravenous morphine

Intervention type

Drug

Phase

Not Applicable

Drug names

Fenatanyl, morphine

Primary outcome measures

Pain measured on an appropriate numeric pain rating scale, 10 minutes after administration of study medication

Secondary outcome measures

1. Time to analgesic effect: Defined as time to reduction in pain from severe to moderate/mild/no pain (pain score 0-6/10)
2. Need for rescue analgesia: defined as exacerbation of pain requiring supplemental analgesia as per the Our Ladys Childrens Hospital, Crumlin (OLCHC) clinical practice guideline
3. Other secondary effects, including:
3.1. Nausea and vomiting
3.2. Respiratory depression, defined as age-appropriate self-ventilation rate that fails to provide full ventilation and perfusion of the lungs (an oxygen saturation below 95% is deemed significant in the absence of any other aetiology other than trial medications (patients with evidence of chest involvement or chest crisis will be excluded)
3.3. Cardiovascular depression, defined as heart rate and/or blood pressure falling below age-appropriate rates in the absence of any other aetiology
3.4. Sedation level, measured using the University of Michigan Sedation Score, a 5-point scale establishing the child'’s level of arousal

Overall trial start date

01/09/2011

Overall trial end date

01/06/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Ages 1 to– 21 years
2. >10kg
3. Known sickle cell disease presenting with severe pain

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Patient has received parenteral narcotic analgesic within 4 hours of emergency department (ED) presentation
2. Known allergy to fentanyl or morphine
3. Altered level of consciousness
4. Any other contraindication to opiate use
5. Blocked or traumatised nose
6. Pain not secondary to painful sickle cell crisis (PSSC)

Recruitment start date

01/09/2011

Recruitment end date

01/06/2013

Locations

Countries of recruitment

Ireland

Trial participating centre

University College Dublin
Dublin
12
Ireland

Sponsor information

Organisation

University College Dublin (Ireland)

Sponsor details

Belfield
Dublin
4
Ireland

Sponsor type

University/education

Website

http://<www.ucd.ie>

Funders

Funder type

Hospital/treatment centre

Funder name

Our Lady's Children's Hospital, Crumlin

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Ireland

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

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22647439

Publication citations

  1. Protocol

    Barrett MJ, Cronin J, Murphy A, McCoy S, Hayden J, an Fhailí S, Grant T, Wakai A, McMahon C, Walsh S, O'Sullivan R, Intranasal fentanyl versus intravenous morphine in the emergency department treatment of severe painful sickle cell crises in children: study protocol for a randomised controlled trial., Trials, 2012, 13, 74, doi: 10.1186/1745-6215-13-74.

Additional files

Editorial Notes

25/04/2017: Plain English summary added.