Pain Relief of Newborn Preterm Infants During Endotracheal Suctioning

NCT01201954 | Completed Phase 2

• 1 other identifier: SACAROSE01
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Keywords

pain; sucrose; newborn; mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

sucrose

ACTIVE COMPARATOR

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

Drug: sucrose

sterile water

PLACEBO COMPARATOR

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

Drug: sucrose

Interventions

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

Also known as: sugar

sterile water; sucrose

Eligibility Criteria

• Age: Up to 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• preterm infants
• over 12 hours of life
• intubated
• clinically stable
• without use of analgesics or sedatives

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Hospital Agamenon Magalhães, Hospital Barão de Lucena

Recife, Pernambuco, Brazil

Location

MeSH Terms

Conditions

Pain

Interventions

Sucrose; Sugars

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates

Study Officials

• Rita A Almeida, postgraduate

  Universidade Federal de Pernambuco

  PRINCIPAL INVESTIGATOR

• Sônia B Coutinho, Dr.

  Universidade Federal de Pernambuco

  STUDY DIRECTOR

• Pedro I Lira, Dr.

  Universidade Federal de Pernambuco

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 15, 2010
• Study Start: March 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: April 26, 2011

Record last verified: 2010-09

Locations

BR (1)