Continuous Infusion of Fentanyl in Preterm on MV
- Conditions
- PainInfant, Premature, DiseasesRespiration; Insufficient or Poor, Newborn
- Interventions
- Drug: 5% glucose solution
- Registration Number
- NCT00571636
- Brief 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.
- Detailed Description
The primary objective of the study is to evaluate the analgesic superiority of Fentanyl given as 'continuous infusion + boluses' versus 'boluses alone' by comparing pain scores obtained by the application of validated algometric scales for chronic pain (EDIN - Echelle Douleur Inconfort Nouveau-Nè) and acute pain (PIPP- Premature Infant Pain Profile).
The secondary objective of the study is to evaluate the safety equivalence of the above 2 therapeutic regimens by recording:
* Rate of mechanically ventilated newborns at one week of age
* Age at which neonates will reach total enteral feeding
* Age (hours) of first meconium passage
* Incidence of intraventricular haemorrhage (IVH), periventricular leucomalacia (PVL) or death within 28 days of life
* Incidence of bladder globe during the first week of life
* Incidence of hypotension during the first week of life
5.2.1 Pain measurement: during the study phase acute pain will be measured once a day during a heel prick by a validated algometric scale for acute pain (PIPP); chronic pain will be measured 3 times a day by a validated algometric scale for chronic pain (EDIN). Inter-rater reliability has been shown acceptable for both scales (26,27). Moreover, in October 2006 the Coordinating Center organized a theoretical and practical course on the correct application of the PIPP and EDIN scales (26,27) for all the participating centers in order to reduce the inter-Center variability in pain measurement.
The EDIN scores will be recorded in a specific CRF (CRF N°1, p. 15). The PIPP scores will be reported in a specific CRF (CRF N° 1, pp. 8-14).
5.2.2 Painful procedures: the following painful procedures, as well as the action taken to reduce pain, will be recorded in the same CRF (CRF N° 1, pp. 8-14):
* heel pricks
* endotracheal aspirations
* venous blood samplings
* pneumothorax drainage
* peripherally inserted central catheter positioning
* others (specify) 5.2.3 Fentanyl open label boluses administration: all the boluses of open label fentanyl administered according to the criteria reported in paragraph 6.1.1 have to be recorded in a special CRF (CRF N° 1, p. 7).
5.2.4 Instrumental examinations: a heart ultrasound has to be obtained in all newborns in the first week of life in order to diagnose patent ductus arteriosus. Brain ultrasound has to be repeated at 4, 7 days of age and then twice a month or when clinically indicated.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 128
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo 5% glucose solution Patients assigned to this arm will receive continuous infusion of placebo+ open label boluses of Fentanyl if necessary. fentanyl Fentanyl Patients assigned to this arm will receive continuous infusion of fentanyl + open label boluses of Fentanyl if necessary.
- Primary Outcome Measures
Name Time Method 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. 7 days
- Secondary Outcome Measures
Name Time Method Rate of MVd newborns at one week of age;Age at which neonates will reach total enteral feeding;Age of first meconium passage;Incidence of IVH, PVL or death within 28 days of life;Incidence of bladder globe and hypotension during the first week of life until discharge from hospital
Trial Locations
- Locations (1)
St'Orsola-Malpighi General Hospital
🇮🇹Bologna, BO, Italy