Intranasal fentanyl versus intravenous morphine in the emergency department treatment of severe painful sickle cell crises in children: Study protocol for a randomised controlled trial

Hdl Handle:
http://hdl.handle.net/10147/567070
Title:
Intranasal fentanyl versus intravenous morphine in the emergency department treatment of severe painful sickle cell crises in children: Study protocol for a randomised controlled trial
Authors:
Barrett, Michael J; Cronin, John; Murphy, Adrian; McCoy, Siobhan; Hayden, John; an Fhailí, SinéadNic; Grant, Tim; Wakai, Abel; McMahon, Corrina; Walsh, Sean; O’Sullivan, Ronan
Citation:
Trials. 2012 May 30;13(1):74
Issue Date:
30-May-2012
URI:
http://dx.doi.org/10.1186/1745-6215-13-74; http://hdl.handle.net/10147/567070
Abstract:
Abstract Background Children with sickle cell disease (SCD) frequently and unpredictably present to the emergency department (ED) with pain. The painful event is the hallmark acute clinical manifestation of SCD, characterised by sudden onset and is usually bony in origin. This study aims to establish if 1.5mcg/kg of intranasal fentanyl (INF; administered via a Mucosal Atomiser Device, MAD™) is non-inferior to intravenous morphine 0.1 mg/kg in severe SCD-associated pain. Methods/design This study is a randomised,double-blind, double-dummy active control trial of children (weighing more than 10 kg) between 1 year and 21 years of age with severe painful sickle cell crisis. Severe pain is defined as rated seven or greater on a 0 to 10 age-appropriate numeric pain scale or equivalent. The trial will be conducted in a single tertiary urban paediatric ED in Dublin, Ireland. Each patient will receive a single active agent and a single placebo via the intravenous and intranasal routes. All clinical and research staff, patients and parents will be blinded to the treatment allocation. The primary endpoint is severity of pain scored at 10 min from administration of the study medications. Secondary endpoints include pain severity measured at 0, 5, 15, 20, 30, 60 and 120 min after the administration of analgesia, proportion of patients requiring rescue analgesia and incidence of adverse events. The trial ends at 120 min after the administration of the study drugs. A clinically meaningful difference in validated pain scores has been defined as 13 mm. Setting the permitted threshold to 50% of this limit (6 mm) and assuming both treatments are on average equal, a sample size of 30 patients (15 per group) will provide at least 80% power to demonstrate that INF is non-inferior to IV morphine with a level of significance of 0.05. Discussion This clinical trial will inform of the role of INF 1.5mcg/kg via MAD in the acute treatment of severe painful sickle cell crisis in children in the ED setting. Trial registration Current Controlled Trials ISRCTN67469672 and EudraCT no. 2011-005161-20
Language:
en
Keywords:
SICKLE CELL DISEASE; ANALGESIA; PAIN; CHILDREN

Full metadata record

DC FieldValue Language
dc.contributor.authorBarrett, Michael Jen
dc.contributor.authorCronin, Johnen
dc.contributor.authorMurphy, Adrianen
dc.contributor.authorMcCoy, Siobhanen
dc.contributor.authorHayden, Johnen
dc.contributor.authoran Fhailí, SinéadNicen
dc.contributor.authorGrant, Timen
dc.contributor.authorWakai, Abelen
dc.contributor.authorMcMahon, Corrinaen
dc.contributor.authorWalsh, Seanen
dc.contributor.authorO’Sullivan, Ronanen
dc.date.accessioned2015-08-17T09:36:41Zen
dc.date.available2015-08-17T09:36:41Zen
dc.date.issued2012-05-30en
dc.identifier.citationTrials. 2012 May 30;13(1):74en
dc.identifier.urihttp://dx.doi.org/10.1186/1745-6215-13-74en
dc.identifier.urihttp://hdl.handle.net/10147/567070en
dc.description.abstractAbstract Background Children with sickle cell disease (SCD) frequently and unpredictably present to the emergency department (ED) with pain. The painful event is the hallmark acute clinical manifestation of SCD, characterised by sudden onset and is usually bony in origin. This study aims to establish if 1.5mcg/kg of intranasal fentanyl (INF; administered via a Mucosal Atomiser Device, MAD™) is non-inferior to intravenous morphine 0.1 mg/kg in severe SCD-associated pain. Methods/design This study is a randomised,double-blind, double-dummy active control trial of children (weighing more than 10 kg) between 1 year and 21 years of age with severe painful sickle cell crisis. Severe pain is defined as rated seven or greater on a 0 to 10 age-appropriate numeric pain scale or equivalent. The trial will be conducted in a single tertiary urban paediatric ED in Dublin, Ireland. Each patient will receive a single active agent and a single placebo via the intravenous and intranasal routes. All clinical and research staff, patients and parents will be blinded to the treatment allocation. The primary endpoint is severity of pain scored at 10 min from administration of the study medications. Secondary endpoints include pain severity measured at 0, 5, 15, 20, 30, 60 and 120 min after the administration of analgesia, proportion of patients requiring rescue analgesia and incidence of adverse events. The trial ends at 120 min after the administration of the study drugs. A clinically meaningful difference in validated pain scores has been defined as 13 mm. Setting the permitted threshold to 50% of this limit (6 mm) and assuming both treatments are on average equal, a sample size of 30 patients (15 per group) will provide at least 80% power to demonstrate that INF is non-inferior to IV morphine with a level of significance of 0.05. Discussion This clinical trial will inform of the role of INF 1.5mcg/kg via MAD in the acute treatment of severe painful sickle cell crisis in children in the ED setting. Trial registration Current Controlled Trials ISRCTN67469672 and EudraCT no. 2011-005161-20en
dc.language.isoenen
dc.subjectSICKLE CELL DISEASEen
dc.subjectANALGESIAen
dc.subjectPAINen
dc.subjectCHILDRENen
dc.titleIntranasal fentanyl versus intravenous morphine in the emergency department treatment of severe painful sickle cell crises in children: Study protocol for a randomised controlled trialen
dc.language.rfc3066enen
dc.rights.holderBarrett et al.; licensee BioMed Central Ltd.en
dc.date.updated2015-08-14T13:26:09Zen
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