Condition category
Haematological Disorders
Date applied
04/03/2011
Date assigned
01/06/2011
Last edited
23/11/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 4

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 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 below 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

Difference in pain score reduction between study arms on an appropriate numeric pain rating scale, measured 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 as defined by 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: we define as heart rate and/or blood pressure falling below age appropriate rates in the absence of any other aetiology
3.4. Sedation level (University of Michigan Sedation Score) which is 5 point scale establishing the child’s level of arousal

University of Michigan Sedation Score
0=Awake/alert
1=Mildly sedated: Tired/Sleepy, appropriate response to verbal sounds
2=Moderately sedated: Somnolent/sleeping. Easily aroused with tactile stimuli
3=Deeply sedated: Deep sleep, arousable only by significant physical stimuli
4=Unarousable

Overall trial start date

01/09/2011

Overall trial end date

01/06/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Ages 1 – 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

School of Medicine & Medical Science
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

National Children's Research Centre, Our Lady's Children's Hospital (Ireland)

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

1. 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