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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Premedication with atropine and morphine |
|
| 2 | Active Comparator | Premedication with glycopyrronium, thiopental, suxamethonium and remifentanil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tracheal intubation for respiratory care in preterm infants | Procedure | Premedication with atropine 0.02 mg/kg and morphine 0.03 mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6-9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score at intubation | 6-9 months | |
| Biochemical stress/pain response | 6-9 months | |
| Physiological stress/pain response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vineta Fellman, Professor | Lund University and Lund University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neonatal Departement Lund University Hospital | Lund | 221 85 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23128421 | Derived | Norman E, Wikstrom S, Rosen I, Fellman V, Hellstrom-Westas L. Premedication for intubation with morphine causes prolonged depression of electrocortical background activity in preterm infants. Pediatr Res. 2013 Jan;73(1):87-94. doi: 10.1038/pr.2012.153. Epub 2012 Nov 5. | |
| 21798556 | Derived | Norman E, Wikstrom S, Hellstrom-Westas L, Turpeinen U, Hamalainen E, Fellman V. Rapid sequence induction is superior to morphine for intubation of preterm infants: a randomized controlled trial. J Pediatr. 2011 Dec;159(6):893-9.e1. doi: 10.1016/j.jpeds.2011.06.003. Epub 2011 Jul 27. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D007442 | Intubation, Intratracheal |
| D012138 | Respiratory Therapy |
| ID | Term |
|---|---|
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
| D008919 | Investigative Techniques |
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| Tracheal intubation for respiratory care in preterm infants | Procedure | Premedication with glycopyrronium 0.005 mg/kg, thiopental 2-3 mg/kg (< 2 kg 2 mg/kg), suxamethonium 2 mg/kg and remifentanil 0.001 mg/kg |
|
| 6-9 months |
| Behavioural stress/pain response | 6-9 months |
| Neurophysiological stress/pain response (aEEG) | 6-9 months |
| D000091642 | Urogenital Diseases |