Pain Relief of Newborn Preterm Infants During Endotracheal Suctioning (PRPS)

This study has been completed.
Sponsor:
Information provided by:
Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier:
NCT01201954
First received: September 14, 2010
Last updated: April 25, 2011
Last verified: September 2010

September 14, 2010
April 25, 2011
March 2010
April 2011   (final data collection date for primary outcome measure)
clinical pain score [ Time Frame: within the first twelve hours after clinical stabilization, the PIPP will be done. ] [ Designated as safety issue: No ]
The tool that will be used is PIPP = Premature Infant Pain Profile. This avaliation begins prior to suctioning until 30 seconds after suctioning. Each infant will be avaliated 2 times (with sucrose and with placebo). The 2 avaliations in the same day.
clinical pain score [ Time Frame: only one day ] [ Designated as safety issue: No ]
The tool that will be used is PIPP = Premature Infant Pain Profile
Complete list of historical versions of study NCT01201954 on ClinicalTrials.gov Archive Site
Not Provided
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Pain Relief of Newborn Preterm Infants During Endotracheal Suctioning
Pain Relief of Newborn Preterm Infants During Endotracheal Suctioning: a Randomized Clinical Trial

Evaluate the effectiveness of the use of a 24% sucrose solution for pain management of preterm infants during endotracheal suctioning.

Many infants admitted to neonatal intensive care unit (NICU) undergo repeated invasive procedures. Recent studies have shown that the oral sucrose administration to neonates is safe and effective for pain relief during heel stick and venipuncture.Most data suggest the investigation of the effect of sucrose in other painful procedures such as in ventilated newborns.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain
Drug: sucrose
oral sucrose solution, 24%, 0,5 ml/kg, 2 minutes before start the suctioning sterile water, 0,5 ml/kg, 2 minutes before start the suctioning
Other Name: sugar
  • Active Comparator: sucrose
    0,5 ml/kg of sucrose administered 2 minutes prior the procedure
    Intervention: Drug: sucrose
  • Placebo Comparator: sterile water
    0,5 ml/kg of sterile water administered 2 minutes prior the procedure
    Intervention: Drug: sucrose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
April 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • preterm infants
  • over 12 hours of life
  • intubated
  • clinically stable
  • without use of analgesics or sedatives

Exclusion Criteria:

  • preterms with congenital malformations
  • preterms with genetic syndromes
  • preterms with Apgar score at 5´<7
  • preterms with meningitis
  • preterms with diagnosed of necrotizing enterocolitis Ouvir Ler foneticamente
Both
up to 36 Weeks
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01201954
SACAROSE01
No
Rita de Cássia de Albuquerque Almeida, Pós-graduação em Saúde da Criança e do Adolescente - UFPE
Universidade Federal de Pernambuco
Not Provided
Principal Investigator: Rita A Almeida, postgraduate Universidade Federal de Pernambuco
Study Director: Sônia B Coutinho, Dr. Universidade Federal de Pernambuco
Study Director: Pedro I Lira, Dr. Universidade Federal de Pernambuco
Universidade Federal de Pernambuco
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP