Children requiring intubation and ventilation for more than 48 hours Not Applicable Sedation
Conditions
Interventions
Clonidine versus midazolam
Sponsors
United Bristol Healthcare NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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 PICU
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adequate sedation defined as at least 80% of total time spent within a comfort score range of 17 to 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 09/05/2008: During study treatment phase: 1. Time to reach the maximum permitted dose of sedation 2. Time to reach the maximum permitted dose of morphine 3. Profile in rise of daily cumulative sedative infusion 4. Profile in rise of daily cumulative morphine infusion 5. Maximum permitted dose of sedative reached 6. Maximum permitted dose of morphine reached 7. Fall in blood pressure judged by clinician to require intervention 8. Increased inotropic support required in 1st 12 hours after randomisation 9. Supplementary analgesia required during sedation 10. Daily urine output 11. Treatment failure defined as inadequate sedation after one hour of maximum doses of sedative and morphine infusions (determined by a COMFORT score above 26) 12. Urinary concentration of gamma glutamyl transpeptidase (Bristol only) 13. Urinary concentration of alkaline phosphatase (Bristol only) Following study treatment phase: 14. Time from stopping all sedation to being fully awake (recorded by COMFORT score as sustained* values of 22 or more). 15. Rebound hypertension 16. Signs of withdrawal measured using a 11 point assessment for abnormal behaviour 17. Withdrawal symptoms requiring clinical intervention * Sustained for 2 hours or more. Throughout the duration of study: 18. Adverse events Health economics: 19. Cost per additional case of adequate sedation Previous secondary outcome measures: 1. Treatment failure defined as 3rd hour sedation judged to still be inadequate (determined by a comfort score outside the range 17 to 26) 2. Adverse events 3. Maximum dose of morphine administered 4. Time to reach maximum dose of morphine 5. Maximum sedation infusion rate reached 6. Time to reach maximum dose of sedation 7. Time to recovery, defined as time from stopping all sedation to being fully awake (recorded by COMFORT score as sustained values of 22 or more). 8. Renal function (evaluated with urinary concentration of gamma glutamyl transpeptidase a | — |
Countries
United Kingdom
Outcome results
None listed