Respiratory Distress Syndrome Clinical Trial
Official title:
Comparative Study of the Use of Remifentanil Versus Morphine for Sedation and Analgesia of Premature Neonates During Mechanical Ventilation in the Treatment of Respiratory Distress Syndrome (RDS)
In this randomised controlled study we intended to compared intubation conditions and the continuous infusion of remifentanil (n=10) and morphine (n=10) in mechanically ventilated premature neonates (28-34wk) regarding the time to be awake and, the time until extubation after interruption of the opioid administration.
Status | Completed |
Enrollment | 0 |
Est. completion date | November 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 28 Days |
Eligibility |
Inclusion Criteria: - Gestational age between 28 and 34 wk - Clinical and radiological features compatible with respiratory distress syndrome that required an elective tracheal intubation and surfactant therapy. Exclusion criteria: - The presence of major congenital malformations - Birth weigh less than 1000g - Previous or concurrent use of opioid for any reason (cesarean section with general anaesthesia) - Hemodynamic instability before the indication of tracheal intubation - Refuse of the parents to enroll the neonate in the study protocol |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Federal University of Minas Gerais |
Pereira e Silva Y, Gomez RS, Barbosa RF, Simões e Silva AC. Remifentanil for sedation and analgesia in a preterm neonate with respiratory distress syndrome. Paediatr Anaesth. 2005 Nov;15(11):993-6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intubation conditions using a four point scale | |||
Primary | Decrease in time after interruption of sedation until the neonate be awake. | |||
Primary | Decrease in time after interruption of sedation until the neonate be extubated. | |||
Secondary | Pain and stress before and after intubation (NIPS and Comfort scores). | |||
Secondary | Pain and stress during continuous infusion of remifentanil versus morphine during mechanical ventilation for the treatment of respiratory distress syndrome (NIPS and Comfort scores). |
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