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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN67469672

Enrollment

Registered

2011-06-01

Start date

2011-09-01

Completion date

Unknown

Last updated

2020-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Painful sickle cell crisis Haematological Disorders Sickle-cell anaemia with crisis

Interventions

Intranasal fentanyl or intravenous morphine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Ages 1 to? 21 years 2. >10kg 3. Known sickle cell disease presenting with severe pain

Exclusion criteria

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 26, 2026