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Intranasal Fentanyl Versus Intravenous Morphine in the Treatment of Severe Painful Sickle Cell Crises in Children

NCT03682211 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2018-09-24

No results posted yet for this study

Summary

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

Interventions

DRUG

Fentanyl Citrate

50 μg/ml fentanyl citrate (Sublimaze, Janssen Cilag, Ltd, Marketing Authorisation No. PA 0748/044/001) administered intranasally using the MAD Nasal Intranasal Mucosal Atomiser Device

DRUG

Morphine sulphate

10 mg/ml Morphine sulphate BP (Antigen Pharmaceuticals, Marketing Authorisation No.PA 73/20/1) administered intravenously.

Sponsors & Collaborators

  • National Children's Research Centre

    collaborator UNKNOWN

  • Our Lady's Children's Hospital, Crumlin

    collaborator UNKNOWN

  • University College Dublin

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-12
Primary Completion
2013-11-14
Completion
2013-11-14

Countries

  • Ireland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03682211 on ClinicalTrials.gov