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 |
| EudraCT/CTIS number | 2011-005161-20 |
| ClinicalTrials.gov number | NCT03682211 |
| Secondary identifying numbers | 08051980 |
- 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
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
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 |
|---|---|
| ronan.osullivan@olchc.ie |
Study information
| Study design | Randomised controlled double-blind trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the conatct details to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/09/2011 |
| Completion date | 01/06/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Year |
| Upper age limit | 21 Years |
| Sex | Both |
| Target number of participants | 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
12
Ireland
Sponsor information
University/education
Belfield
Dublin
4
Ireland
| Website | http://<www.ucd.ie> |
|---|---|
"ROR" |
https://ror.org/05m7pjf47 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Universities (academic only)
- Location
- Ireland
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
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.
