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Pain Relief of Newborn Preterm Infants During Endotracheal Suctioning

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01201954
Acronym
PRPS
Enrollment
43
Registered
2010-09-15
Start date
2010-03-31
Completion date
2011-04-30
Last updated
2011-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

pain, sucrose, newborn, mechanical ventilation

Brief summary

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

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.

Interventions

DRUGsucrose

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

Sponsors

Universidade Federal de Pernambuco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 36 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
clinical pain scorewithin 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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026