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

Universidade Federal de Pernambuco

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Drug: sucrose

Study type: Interventional

Funder types: Other

Identifiers

NCT01201954

SACAROSE01

Details and patient eligibility

About

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

Full 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.

Enrollment: 43 patients

Sex: All

Ages: Under 36 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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43 participants in 2 patient groups, including a placebo group

sucrose

Active Comparator group

Description:

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

Treatment:

Drug: sucrose

sterile water

Placebo Comparator group

Description:

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

Treatment:

Drug: sucrose