Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0045125254
Study information
Scientific title
Acronym
Study hypothesis
Does monitoring neuromuscular function on PICU (Paediatric Intensive Care Unit) have any advantages over standard practice of clinical assessment of neuromuscular function/drug requirements?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Condition
Nervous System Diseases: Neuromuscular function
Intervention
Patients randomly allocated to received either standard management of NMBD (neuromuscular blocking drug) administration or protocol driven according to monitored neuromuscular function.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Total amount of NMBD administered
2. Speed of recovery or neuromuscular function once NMBDs stopped
3. Complications related to residual NM paralysis
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/06/2002
Overall trial end date
31/05/2003
Reason abandoned
Eligibility
Participant inclusion criteria
30 patients under the age of 16 years requiring administration of Rocuronium to facilitate mechanical ventilation for more than 48 hours.
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
30
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/06/2002
Recruitment end date
31/05/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Birmingham Children's Hospital
Birmingham
B4 6NH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Birmingham Children's Hospital NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary