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Pain Relief of Newborn Preterm Infants During Endotracheal Suctioning

Phase 2
Completed
Conditions
Pain
Interventions
Registration Number
NCT01201954
Lead Sponsor
Universidade Federal de Pernambuco
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
43
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
sucrosesucrose0,5 ml/kg of sucrose administered 2 minutes prior the procedure
sterile watersucrose0,5 ml/kg of sterile water administered 2 minutes prior the procedure
Primary Outcome Measures
NameTimeMethod
clinical pain scorewithin the first twelve hours after clinical stabilization, the PIPP will be done.

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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Hospital Agamenon Magalhães, Hospital Barão de Lucena

🇧🇷

Recife, Pernambuco, Brazil

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