Balanced Anesthesia for Intubation of Newborn Premature Infants - a Randomized Intervention Study
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Premature Birth
- Sponsor
- Lund University Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Success of intubation according to a specific score including duration of the procedure and changes in oxygen saturation, blood pressure and heart rate during the intubation
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief Summary
The study aim is to compare a balanced anesthesia of the medicines used in all other age groups with the routine premedication in use for premature's with regards to the success in the intubation procedure, the need for analgesia during and after intubation and the stress reaction. In addition a pain scale for prolonged stress/pain for premature neonates in NICU-care will be validated, and the individual pharmacogenetic profile in relation to the need of morphine after the intubation will be investigated. The hypothesis is that balanced anesthesia before intubation facilitates the procedure, decreases the amount of stress and pain related to it, and causes a decreased need for analgesia after the intubation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\<37 gw at birth
- •\<72 hours postnatal age, not previously intubated and no analgetics or sedatives the last 12 hours or \>72 hours postnatal age, primary or reintubation
- •Informed consent from parents
Exclusion Criteria
- •Intubation directly postnatally at the delivery room
- •Asphyxia (apgar \<4 at 10 min, Umb-pH \<7,0
- •S-Potassium \> 6,5
- •Major malformations
- •Postsurgery intubation
- •Included in an other intervention study first week in life
- •Other intervention study
Outcomes
Primary Outcomes
Success of intubation according to a specific score including duration of the procedure and changes in oxygen saturation, blood pressure and heart rate during the intubation
Time Frame: 6-9 months
Secondary Outcomes
- Pain score at intubation(6-9 months)
- Biochemical stress/pain response(6-9 months)
- Physiological stress/pain response(6-9 months)
- Behavioural stress/pain response(6-9 months)
- Neurophysiological stress/pain response (aEEG)(6-9 months)