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Continuous Infusion of Fentanyl in Preterm on MV

This study has been completed.
Sponsor:
Collaborator:
Agenzia Italiana del Farmaco
Information provided by (Responsible Party):
Ancora Gina, St. Orsola Hospital
ClinicalTrials.gov Identifier:
NCT00571636
First received: December 11, 2007
Last updated: October 8, 2011
Last verified: October 2011
History of Changes
  Purpose

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.

Condition Intervention Phase
Pain
Infant, Premature, Diseases
Respiration; Insufficient or Poor, Newborn
 Drug: Fentanyl
Drug: 5% glucose solution
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Continuous Infusion of Fentanyl for Pain Control in Preterm Newborn on Mechanical Ventilation

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
U.S. FDA Resources

Further study details as provided by St. Orsola Hospital:

Primary Outcome Measures:
  • 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. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: until discharge from hospital ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 128
Study Start Date: December 2007
Study Completion Date: July 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: fentanyl
Patients assigned to this arm will receive continuous infusion of fentanyl + open label boluses of Fentanyl if necessary.
 Drug: Fentanyl

The experimental drug will be diluted according to each NICU scheme and administered as an attach dose of 1 mcg/kg in 30' followed by continuous i.v. infusion of 1 mcg/kg/h. Infusion of the experimental drug has to begin within 24 hrs from the beginning of MV and has to be continued until the end of MV and not after 7 days of life. If the newborn is still on MV after the 7th day of life he/she will be treated for pain according to local protocols.

Open label boluses of Fentanyl during the study phase will be administered, in both groups when the EDIN pain score is > 6 and before performing the following invasive procedures:Peripherally inserted central venous catheter positioning;Re-intubation;Lumbar puncture;Pneumothorax or hydrothorax drainage.
Placebo Comparator: placebo
Patients assigned to this arm will receive continuous infusion of placebo+ open label boluses of Fentanyl if necessary.
 Drug: 5% glucose solution
ev continuous infusion

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

Ages Eligible for Study:   up to 32 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00571636

Locations
Italy
St'Orsola-Malpighi General Hospital
Bologna, BO, Italy, 40138
Sponsors and Collaborators
St. Orsola Hospital
Agenzia Italiana del Farmaco
Investigators
Principal Investigator: Gina Ancora, Doctor St'Orsola-Malpighi General Hospital
  More Information

No publications provided

Responsible Party: Ancora Gina, MD, St. Orsola Hospital
ClinicalTrials.gov Identifier: NCT00571636     History of Changes
Other Study ID Numbers: NEO 01/2005, FARM63TMS3
Study First Received: December 11, 2007
Last Updated: October 8, 2011
Health Authority: Italy: The Italian Medicines Agency
Italy: Ethics Committee

Keywords provided by St. Orsola Hospital:
Opioids infusion
mechanical ventilation

Additional relevant MeSH terms:
Infant, Premature, Diseases
Infant, Newborn, Diseases
Fentanyl
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
 Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 19, 2013