Condition category
Nervous System Diseases
Date applied
24/10/2009
Date assigned
05/11/2009
Last edited
05/11/2009
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 Ingrid Egerod

ORCID ID

Contact details

The University Hospitals Center for Nursing and Care Research (UCSF)
Rigshospitalet Dept. 7331
Blegdamsvej 9
Copenhagen
DK-2100
Denmark
+45 3545 7365
ie@ucsf.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2093

Study information

Scientific title

Effect of an analgo-sedation protocol for neurointensive patients: a two-phase interventional non-randomised pilot study

Acronym

Study hypothesis

It was hypothesised that the sedation protocol would promote a shift from sedation-based to analgesia-based sedation, and show signs of improved pain management.

Ethics approval

1. Danish Data Protection Agency, approved on 21/12/2006 (J.nr.2006-41-7419)
2. Danish National Committee on Biomedical Research Ethics, approved on 06/12/2006 (J.nr.KF01-2006-4507)

Study design

Interventional non-randomised controlled single-centre trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Condition

Sedation and pain management in mechanically ventilated neurointensive care patients

Intervention

100 participants were recruited while the previous sedation practice was in effect, and new 100 participants were recruited after the introduction of the new sedation protocol (200 participants recruited in total).

The new protocol included the following:
1. Pain medication should be given before a sedative
2. A sedative should be used only if necessary
3. Remifentanil should be used for short-term sedation
4. Fentanyl should be used for traumatic brain injury

Intervention type

Drug

Phase

Not Applicable

Drug names

Remifentanil, Fentanyl

Primary outcome measures

1. A shift from sedation-based to analgesia-based sedation (analgo-sedation), assessed from the chages in the use of sedatives and analgesic agents in each patient
2. Improved pain management, assessed daily in each patient using the Pain Intensity (PI) scale

For all primary and secondary outcome measures, the participants were followed-up until they were off mechanical ventilation and sedation.

Secondary outcome measures

1. Incidence of late pneumonia. Late pneumonia was defined as pneumonia acquired >48 hours after intubation.
2. Accidental extubations
3. Duration of sedation

For all primary and secondary outcome measures, the participants were followed-up until they were off mechanical ventilation and sedation.

Overall trial start date

01/01/2007

Overall trial end date

01/10/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, >17 years old
2. Admitted to the neurointensive care unit (NICU)
3. Tracheally intubated within 24 hours
4. Mechanically ventilated
5. Receiving continuous infusions of sedatives and analgesics

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Potential organ donors
2. Non-sedated and non-intubated patients
3. Patients transferred intubated from other units

Recruitment start date

01/01/2007

Recruitment end date

01/10/2008

Locations

Countries of recruitment

Denmark

Trial participating centre

The University Hospitals Center for Nursing and Care Research (UCSF)
Copenhagen
DK-2100
Denmark

Sponsor information

Organisation

Copenhagen University Hospital (Denmark)

Sponsor details

c/o Dr Karen-Lise Welling
Neurointensive Unit 2093
Department of Neuroanaesthesiology
The Neuroscience Centre
Rigshospitalet
Copenhagen
DK-2100
Denmark

Sponsor type

Hospital/treatment centre

Website

http://www.rigshospitalet.dk

Funders

Funder type

Hospital/treatment centre

Funder name

Copenhagen University Hospital Rigshospitalet (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The University Hospitals Centre for Nursing and Care Research (Denmark)

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