Condition category
Nervous System Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
13/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Oliver Bagshaw

ORCID ID

Contact details

Birmingham Children's Hospital
Department of Anaesthesia
Steelhouse Lane
Birmingham
B4 6NH
United Kingdom

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes