Is intranasal fentanyl no worse than intravenous morphine in the treatment of painful sickle cell crisis in the paediatric emergency department?

ISRCTN	ISRCTN67469672
DOI	https://doi.org/10.1186/ISRCTN67469672
ClinicalTrials.gov (NCT)	NCT03682211
Clinical Trials Information System (CTIS)	2011-005161-20
Protocol serial number	08051980
Sponsor	University College Dublin (Ireland)
Funder	Our Lady's Children's Hospital, Crumlin

Submission date: 04/03/2011
Registration date: 01/06/2011
Last edited: 28/05/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Haematological Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Ronan O'Sullivan
Scientific

School of Medicine & Medical Science
University College Dublin
Our Lady's Children's Hospital Crumlin
Dublin
12
Ireland

Phone	+353 (0)1 409 6100/6324
Email	ronan.osullivan@olchc.ie

Study information

Primary study design	Interventional
Study design	Randomised controlled double-blind trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Painful sickle cell crisis
Intervention	Intranasal fentanyl or intravenous morphine
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Fenatanyl, morphine
Primary outcome measure(s)	Pain measured on an appropriate numeric pain rating scale, 10 minutes after administration of study medication
Key secondary outcome measure(s)	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
Completion date	01/06/2013

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	1 Year
Upper age limit	21 Years
Sex	All
Target sample size at registration	40
Total final enrolment	31
Key inclusion criteria	1. Ages 1 to 21 years 2. >10kg 3. Known sickle cell disease presenting with severe pain
Key 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)
Date of first enrolment	01/09/2011
Date of final enrolment	01/06/2013

Locations

Countries of recruitment

Ireland

Study participating centre

University College Dublin

Dublin
12
Ireland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	30/05/2012		Yes	No
Basic results			28/05/2020	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
13/02/2020: ClinicalTrials.gov number added.
25/04/2017: Plain English summary added.