Balanced Anesthesia for Intubation of Premature Infants

Lund University Hospital

Status and phase: Completed; Phase 4

Conditions: Premature Birth

Treatments: Procedure: Tracheal intubation for respiratory care in preterm infants

Study type: Interventional

Funder types: Other

Identifiers

NCT00216944

EUDRACT EU 2004-001583-52

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

1

Active Comparator group

Description:

Premedication with atropine and morphine

Treatment:

Procedure: Tracheal intubation for respiratory care in preterm infants

Procedure: Tracheal intubation for respiratory care in preterm infants

2

Active Comparator group

Description:

Premedication with glycopyrronium, thiopental, suxamethonium and remifentanil

Treatment:

Procedure: Tracheal intubation for respiratory care in preterm infants

Procedure: Tracheal intubation for respiratory care in preterm infants