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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22647439
Publication citations
-
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.