SLEEPS: Safety profiLe, Efficacy and Equivalence in Paediatric intensive care Sedatio

Not Applicable

Completed

• Conditions: Children requiring intubation and ventilation for more than 48 hours; Not Applicable; Sedation

• Registration Number: ISRCTN02639863
• Lead Sponsor: nited Bristol Healthcare NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-25
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Current inclusion criteria as of 09/05/2008:
1. Children aged 30 days (37 weeks gestation or greater) to 15 years inclusive
2. Admitted to Paedatric Intensive Care Unit (PICU) and likely to require intubation and ventilation for more than 48 hours
3. Recruitment within 48 hours of arrival in PICU
4. Adequately sedated: COMFORT score within the range of greater than or equal to 17 and less than or equal to 26
5. Fully informed written proxy consent

Previous inclusion criteria:
1. Children aged 30 days to 16 years
2. Admitted to PICU and likely to require intubation and ventilation for more than 48 hours
3. Recruitment within 48 hours of arrival in PIC

Exclusion Criteria

Current exclusion criteria as of 09/05/2008:
1. Those patients with open chests following cardiac surgery
2. Those patients chronically treated for raised blood pressure
3. Current treatment with beta blockers
4. Acute traumatic brain injury
5. Those patients requiring haemodialysis
6. Those patients requiring ECMO treatment
7. Those patients with severe neuromuscular problems/impairment
8. Known allergy to either of the trial medications (clonidine, midazolam or morphine)
9. Current treatment with continuous or intermittent muscle relaxants
10. Those patients known to be pregnant
11. Currently participating in a conflicting clinical study or participation in a clinical study involving a medicinal product in the last three months

Previous exclusion criteria:
1. Those patients with open chests following cardiac surgery
2. Those patients chronically treated for raised blood pressure
3. Current treatment with beta blockers
4. Acute traumatic brain injury
5. Known allergy to either of the trial medications (clonidine, midazolam or morphine)
6. Current treatment with continuous or intermittent muscle relaxants

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adequate sedation defined as at least 80% of total time spent within a comfort score range of 17 to 26