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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: sucrose

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil
      • Hospital Agamenon Magalhães, Hospital Barão de Lucena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: sugar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical pain score	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.	within the first twelve hours after clinical stabilization, the PIPP will be done.

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: September 14, 2010
• First Submitted That Met QC Criteria: September 14, 2010
• First Posted (Estimate): September 15, 2010

Study Record Updates

• Last Update Posted (Estimate): April 26, 2011
• Last Update Submitted That Met QC Criteria: April 25, 2011
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: pain; mechanical ventilation; newborn; sucrose
• Other Study ID Numbers: SACAROSE01