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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
History of Changes
  Purpose

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


Condition Intervention Phase
Pain
 Drug: sucrose
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pain Relief of Newborn Preterm Infants During Endotracheal Suctioning: a Randomized Clinical Trial

Resource links provided by NLM:

Drug Information available for: Sucrose
U.S. FDA Resources

Further study details as provided by Universidade Federal de Pernambuco:

Primary Outcome Measures:
  • 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.


Enrollment: 43
Study Start Date: March 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: sucrose
0,5 ml/kg of sucrose administered 2 minutes prior the procedure
 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
Placebo Comparator: sterile water
0,5 ml/kg of sterile water administered 2 minutes prior the procedure
 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 36 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01201954

Locations
Brazil
Hospital Agamenon Magalhães, Hospital Barão de Lucena
Recife, Pernambuco, Brazil
Sponsors and Collaborators
Universidade Federal de Pernambuco
Investigators
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
  More Information

No publications provided

Responsible Party: Rita de Cássia de Albuquerque Almeida, Pós-graduação em Saúde da Criança e do Adolescente - UFPE
ClinicalTrials.gov Identifier: NCT01201954     History of Changes
Other Study ID Numbers: SACAROSE01
Study First Received: September 14, 2010
Last Updated: April 25, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Federal de Pernambuco:
pain
sucrose
newborn
mechanical ventilation

ClinicalTrials.gov processed this record on May 16, 2013