Continuous Infusion of Fentanyl in Preterm on MV
Information source: St. Orsola Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain; Infant, Premature; Respiration, Artificial; Analgesia
Intervention: Fentanyl (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: St. Orsola Hospital Official(s) and/or principal investigator(s):
Gina Ancora, Doctor, Principal Investigator, Affiliation: St'Orsola-Malpighi General Hospital
Overall contact:
Gina Ancora, Doctor, Phone: +390516364463, Email: gina.ancora@unibo.it
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.
Clinical Details
Official title: Efficacy and Safety of Continuous Infusion of Fentanyl for Pain Control in Preterm Newborn on Mechanical Ventilation
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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.
Secondary outcome: 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
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.
Eligibility
Minimum age: N/A.
Maximum age: 32 Weeks.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Gina Ancora, Doctor, Phone: +390516364463, Email: gina.ancora@unibo.it
St'Orsola-Malpighi General Hospital, Bologna, BO 40138, Italy; Recruiting
Gina Ancora, Doctor, Phone: +396364463, Email: gina.ancora@unibo.it
Additional Information
Starting date: May 2007
Ending date: May 2010
Last updated: December 11, 2007
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