Pain Relief of Newborn Preterm Infants During Endotracheal Suctioning

Pain Clinical Trial

— PRPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01201954
• Other study ID #: SACAROSE01
• Status: Completed
• Phase: Phase 2
• First received: September 14, 2010
• Last updated: April 25, 2011
• Start date: March 2010
• Est. completion date: April 2011

Study information

• Verified date: September 2010
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 36 Weeks

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital Agamenon Magalhães, Hospital Barão de Lucena	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No