CompletedPhase 3

Continuous Infusion of Fentanyl in Preterm on MV

Italy128 participantsStarted 2007-12

Plain-language summary

The objective of this randomized, double-blind trial is to compare the efficacy and safety of 2 therapeutic regimens of fentanyl administration in a population of preterm newborns of GA \<= 32 weeks in MV: * Group A) continuous infusion of Fentanyl + open label boluses of Fentanyl; * Group B) continuous infusion of placebo + open label boluses of Fentanyl.

Who can participate

Age range32 Weeks

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * inborn neonates * preterm neonates ≤ 32+ 6 days weeks gestation * \< 72 hours of life * newborns on MV * within 24 hours from the beginning of MV administered through an endotracheal tube * parental written informed consent for participation in the study must be obtained Exclusion Criteria: * Evidence of severe birth asphyxia, that is an APGAR score below 4 at 5 minutes of age and/or umbilical arterial pH \< 7.0 * Known genetic or chromosomal disorders * Severe IVH (\> grade II according to Volpe classification (30)) * Need for post-operative analgesic therapy in the first week of life * Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol

What they're measuring

The primary efficacy variable for this study will be the pain scores obtained during the study period. Procedural pain will be measured once a day by the PIPP scale. Chronic pain will be evaluated through the application of the EDIN scale 3 times a day.

Timeframe: 7 days

Trial details

NCT IDNCT00571636

SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-04

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