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Completed

NCT Number: NCT01201954

Pain Relief of Newborn Preterm Infants During Endotracheal Suctioning

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

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 36 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Agamenon Magalhães, Hospital Barão de Lucena

Recife, Pernambuco, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sucrose

Drug

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 names: sugar

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Official study title

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

Acronym: PRPS

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 15, 2010
Registry last updated
Apr 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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