Term healthy newborns who receive the BCG vaccine. Infant, Newborn, Pain, Analgesia, Breastfeeding, Kangaroo Mother Care Method, Glucose, BCG vaccine, Neonatal Nursing
Conditions
Interventions
The sample consisted by 109 healthy term newborns, admitted to the Rooming HU / USP, between August and September 2015. The sample was randomized into two groups, and 55 were allocated to the Experime
Other
E03.091
H02.478.676.390.600
Sponsors
Escola de Enfermagem da USP
Hospital Universitário da USP
Eligibility
Inclusion criteria
Inclusion criteria: The infants who meet the following criteria will be included in the study : Internees in rooming unit; Exclusive breastfeeding without medical records of difficulty to handle and sucking the mother's womb ; With gestational age between 37 and 41 weeks and 6 days of birth ; Last feed occurring for at least 1 hour before vaccination; BCG vaccination indication; No analgesic use history or sedative; Absence of fractures and tocotraumas ; and absence of nausea or vomiting within the last 2 hours preceding the administration of the BCG vaccine.
Exclusion criteria
Exclusion criteria: Will be excluded from the study newborns who present : Congenital disease diagnosis of the nervous system malformations or neurological damage established after receiving the BCG vaccination; Fracture diagnosis or established tocotraumatism after receiving the BCG vaccine; and application of the vaccine dose or in non-compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain score obtained by applying the scale Premature Infant Pain Profile- Revised ( PIPP -R) every 30 seconds for 3 minutes after administration of the BCG vaccine. For allocation of points that making up the PIPP -R scale, they were raised gestational age of the newborn, the behavioral state, the maximum and minimum heart rates , and the minimum saturation of oxygen, before the painful procedure. After application of the vaccine, every 30 seconds were evaluated variations of maximum heart frequency and minimum oxygen saturation, time in which the newborn kept protruding eyebrows (bulging , formation of folds and above vertical slits and between the eyebrows), the eyes squeezed (squeeze the eyes or bulging eyelids and eyelid folds) and nasolabial folds (elevation and deepening of the nasolabial folds). For each indicator they were assigned scores ranging from zero to three . The final score was calculated by adding the points of the indicators. | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of adverse effects such as nausea, vomiting, coughing, gagging, reflux, oxygen saturation less than 80 %, the heart rate lower than 80 bpm or greater than 200 bpm , among others, observed in the range of 180 seconds after administration of vaccine.;Crying time during the 180 seconds that followed the application of BCG vaccine. The total crying time in seconds was calculated and the percentage of the time of its occurrence during the 180 s observation. It was considered as a manifestation of pain continuous audible vocalization for a period equal to greater than 3 seconds and intervals of less than 3 seconds. | — |
Countries
Brazil
Contacts
Public ContactLuciana Ogawa
Hospital Universitário da Universidade de São Paulo
Outcome results
None listed