Respiratory insufficiency in prematrue infants requiring ventilatory assistance and therefore intubation. Premedication before intubation.
Conditions
Interventions
Trade Name: Ultiva®
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: remifentanil
Concentration unit: mg/ml milligram(s)/millilitre
Concentration number: 0.01 -
Trade Name: Robinul
Phar
Sponsors
Lund University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Gestational age less than 37 weeks at birth Group 1: = 72 h postnatal age not previously intubated not previously received analgetics or sedatives Group 2: > 72 h postnatal age first or repeated intubation 2. written parental informed consent Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Urgent intubation immediately post partum Asphyxia (Apgar <4 at 10 min age, U-pH <7.0) Major malformations Postsurgery intubaiton Other intervention study during the first week of life
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare a balanced anestesia (BA), using the same medicines as in older age groups, with the routine premedication in use. To compare BA (including remifentanil) with morphine with regard to - Success in the intubation procedure - Analgesia during and after intubation - Stress reaction (physiological and biochemical parameters) ;Secondary Objective: 1. To compare pain scales and validate a scale (ALPS) for objective assessment of pain/distress during continuous neonatal intensive care. 2. To assess the individual pharmacogenetic profile in relation to the need of morphine after the intubation. ;Primary end point(s): Success of intubation according to - the Viby-Mogensen scale - assessment of duration of the procedure and changes in oxygen saturation and heart rate during the intubation. | — |
Countries
Sweden
Outcome results
None listed