Glucose 25% and sucking gloved finger for pain relief of premature newborns during capillary glucose by heel prick

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-3gm6w5
• Date of registration: 02/10/2014
• Prospective Registration: No
• Primary sponsor: Escola de Enfermagem Anna Nery da Universidade Federal do Rio de Janeiro
• Public title: Glucose 25% and sucking gloved finger for pain relief of premature newborns during capillary glucose by heel prick
• Scientific title: Glucose 25% and nonnutritive sucking for pain relief in premature undergoing heel lance: a clinical trial
• Date of first enrolment: 30/01/2014
• Recruitment status: Recruiting
• URL: http://ensaiosclinicos.gov.br/rg/RBR-3gm6w5
• Study type: Intervention
• Study design: Crossover clinical trial, randomized controlled, triple-blind, with 3 arms
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Ana Luiza Dorneles da Silveira
• Affiliation: Escola de Enfermagem Anna Nery da Universidade Federal do Rio de Janeiro

• Name: Ana Luiza Dorneles da Silveira
• Affiliation: Escola de Enfermagem Anna Nery da Universidade Federal do Rio de Janeiro

Key inclusion & exclusion criteria

Inclusion criteria: Prematures with gestational age at birth between 29 and 36 weeks complete; age after birth more than 06 hours; apgar score at five minutes of 7 or more; clinical stability with physiologic parameters at heart rate between 120 to 160 and oxygen saturation more than 89%; antecipated clinical need for at least 3 routine heel stick to control blood glucose after six hours post birth
Exclusion criteria: Ventilatory assistance; intraventricular hemorrhage(grades III
and IV)or leukomalacia; cromossomal disorders or malformations affecting central nervous system; disorders affecting cardiovascular system, presence of necrotizing intestinal colitis or hyperglycemia; use of opioids, corticosteroids, or other drugs that interfere with the responses to pain, children of mothers who use illegal drugs, trauma from childbirth as skin lesions, fractures, intracranial hemorrhage, visceral ruptures

Age minimum: 6H
Age maximum: 5D
Gender: -

Health Condition(s) or Problem(s) studied

C10.597.617

PAIN

Intervention(s)

D09.546.359.448

Crossover study with 40 premature newborns and active treatment (glucose 25%, sucking gloved finger, glucose 25% + sucking gloved finger). Each premature newborn will be assessed individually for 3 consecutive days. Day 1: Intervention 1 (1 ml of oral glucose 25%)- 40 premature newborns. Day 2: Intervention 2 (sucking gloved finger)- 40 premature newborns. Day 3: Intervention 3 (1 ml of oral glucose 25% + sucking gloved finger)- 40 premature newborns. The interventions 1, 2 and 3 are offered randomized manner, with a washout of 24 hours. The interventions were done 2 minutes before heel prick procedure

F01.145.916

Other

Primary Outcome(s)

Pain score obtained by Premature Infant Pain Profile (PIPP)during five minutes. The score will be performed in blocks of 30 seconds. Expected scores lower than 7 because the use of interventions to pain relif

Secondary Outcome(s)

Maintenance of heart rate and oxygen saturation in normal levels , reduce time of facial activity and crying

Source(s) of Monetary Support

Ana Luiza Dorneles da Silveira

Secondary Sponsor(s)

Maternidade Escola da Universidade Federal do Rio de Janeiro