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)
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Primary Endpoint
- Intubation conditions using a four point scale
Study Overview
Brief Summary
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.
Detailed Description
Intubation and mechanical ventilation are majors component of intensive care for premature neonates with respiratory distress syndrome (RDS) and is associated with physiologic, biochemical, and clinical responses indicating pain and stress in prematures. Although morphine is one of the most used drugs for premedication and for sedation and analgesia during mechanical ventilation in the treatment of RDS its pharmacological profile precludes several limitations mostly due to its much delayed onset of action what makes the drug not suitable as premedication and due to its prolonged duration of action mainly in prematures. Unlike morphine, remifentanil has an unique pharmacokinetic properties with a rapid onset of action and, a fast decrease in plasma concentration after interruption of administration due to a context-sensitive half-time of 3.2 minutes. So, it could be the ideal opioid for neonates who are especially sensitive to respiratory depression by opioids
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double
Eligibility Criteria
- Ages
- 60 Minutes to 28 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Intubation conditions using a four point scale
Decrease in time after interruption of sedation until the neonate be awake.
Decrease in time after interruption of sedation until the neonate be extubated.
Secondary Outcomes
- Pain and stress before and after intubation (NIPS and Comfort scores).
- Pain and stress during continuous infusion of remifentanil versus morphine during mechanical ventilation for the treatment of respiratory distress syndrome (NIPS and Comfort scores).