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. These blockages prevent oxygen (in blood) from reaching different parts of the body resulting in painful crisis. This study will compare the effectiveness of two types of pain medication, one given through a vein and one squirted up the nose.

• Conditions: Severe Painful Sickle Cell Disease Crises in Children; MedDRA version: 14.1Level: LLTClassification code 10040644Term: Sickle cell diseaseSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2011-005161-20-IE
• Lead Sponsor: niversity College Dublin Clinical Research Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-05
• Last Update Posted: 10 March 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion – Screening
Ages 1 – 21 years;
=10kg and =70kg;
Known sickle cell disease with risk of or a history of painful crisis;
Willing to verbally re-consent during the next period of painful crisis.

Inclusion Criteria - Randomisation:
Ages 1 – 21 years;
=10kg and =70kg;
Known sickle cell disease presenting with severe pain;
Written informed consent, ideally from both parents (and assent, where appropriate), obtained prior to painful crisis;
Verbal consent (and assent, where appropriate) obtained at the time of the painful crisis;
Hospital admission required for painful crisis.

Are the trial subjects under 18? yes
Number of subjects for this age range: 27
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion Criteria – Screening
Previous enrolment into the trial;
Patient has a history of allergic reaction to morphine or fentanyl;
Patient receiving or requiring drug-dependency therapy;
Contraindications to fentanyl usage which include:
o Use in patients with hypersensitivity or idiosyncratic response to the active ingredient;
o Use in patients with respiratory depression, cyanosis, excessive bronchial exudation, asthma attack, or chronic pulmonary disease;
o Use in patients after operative interventions in the biliary tract;
o Use in patients who are receiving, or have within two weeks received, monoamine oxidase inhibitors;
o Use in the presence of acute alcoholism, increased intracranial pressure or coma.
Contraindications to morphine usage which include:
o Hypersensitivity to any of the product ingredients;
o Acute respiratory depression or Chronic Pulmonary Disease;
o Excessive bronchial exudation;
o Asthma attack;
o Acute alcoholism;
o Biliary colic or following biliary tract surgery or surgical anastomosis;
o Head injuries, increased intracranial pressure or coma;
o Heart failure secondary to lung disease;
o Cyanosis;
o Convulsive disorders;
o Use in patients who are receiving, or have within two weeks received monoamine oxidase inhibitors (including moclobemide);
o Risk of paralytic ileus;
o Phaeochromocytoma;
o Blocked or traumatised nose;
o Pain not secondary to PSSC;
o Inability to secure IV access.
Kidney disease, renal dialysis;
Patient is pregnant or breastfeeding;
Patients who have any condition that would make him/her, in the opinion of the Investigator or Sponsor, unsuitable for the study; or who are, in the opinion of the Investigator, not likely to complete the study for any reason.

Exclusion Criteria - Randomisation:
All previous exclusion criteria;
Patient has received parenteral narcotic analgesic within 4 hours of ED presentation;
Saturations below 95% on initial assessment;
Altered conscious state as defined by a Glasgow Coma score less than 15;
Contraindications to fentanyl usage which include:
o Use in patients with hypersensitivity or idiosyncratic response to the active ingredient;
o Use in patients with respiratory depression, cyanosis, excessive bronchial exudation, asthma attack, or chronic pulmonary disease;
o Use in patients after operative interventions in the biliary tract;
o Use in patients who are receiving, or have within two weeks received, monoamine oxidase inhibitors;
o Use in the presence of acute alcoholism, increased intracranial pressure or coma.
Contraindications to morphine usage which include:
o Hypersensitivity to any of the product ingredients;
o Acute respiratory depression or Chronic Pulmonary Disease;
o Excessive bronchial exudation;
o Asthma attack;
o Acute alcoholism;
o Biliary colic or following biliary tract surgery or surgical anastomosis;
o Head injuries, increased intracranial pressure or coma;
o Heart failure secondary to lung disease;
o Cyanosis;
o Convulsive disorders;
o Use in patients who are receiving, or have within two weeks received monoamine oxidase inhibitors (including moclobemide);
o Risk of paralytic ileus;
o Phaeochromocytoma;
o Blocked or traumatised nose;
o Pain not secondary to PSSC;
o Inability to secure IV access.
Patient has participated in another clinical trial involving an IMP within 4 weeks of dosing, or who are currently enrolled in another clinical trial involving an IMP;
Patients who have any condition that would make him/her, in the opini

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to illustrate the comparative efficacy of intranasal fentanyl to IV morphine in reducing severe pain associated with Painful Sickle Cell Crises in the Emergency Department.;Secondary Objective: The secondary objectives of this study include: <br>Assessment of the time to analgesic effect;<br>Assessent of the need for rescue analgesia, defined as exacerbation of pain requiring supplemental analgesia;<br>Assessment of other secondary effects including:<br>o Nausea and vomiting<br>o Respiratory depression<br>o Cardiovascular depression<br>o Sedation level<br>;Primary end point(s): The primary endpoint of this study is the measurement of difference in pain score reduction between study arms, on age-appropriate numeric pain rating scales, measured 10 minutes after administration of study medication.;Timepoint(s) of evaluation of this end point: 10 minutes after administration of study medication.