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Clinical Trials/NCT01201954
NCT01201954
Completed
Phase 2

Pain Relief of Newborn Preterm Infants During Endotracheal Suctioning: a Randomized Clinical Trial

Universidade Federal de Pernambuco1 site in 1 country43 target enrollmentMarch 2010
ConditionsPain
Interventionssucrose
Drugssucrose

Overview

Phase
Phase 2
Intervention
sucrose
Conditions
Pain
Sponsor
Universidade Federal de Pernambuco
Enrollment
43
Locations
1
Primary Endpoint
clinical pain score
Status
Completed
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
April 2011
Last Updated
15 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Eligibility 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

Arms & Interventions

sucrose

0,5 ml/kg of sucrose administered 2 minutes prior the procedure

Intervention: sucrose

sterile water

0,5 ml/kg of sterile water administered 2 minutes prior the procedure

Intervention: sucrose

Outcomes

Primary Outcomes

clinical pain score

Time Frame: within 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.

Study Sites (1)

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