Newborns admitted to neonatal intensive care units are submitted daily to serial blood sample collections through arterial punctures. This repeated exposure to pain can cause immediate and delayed damage. The aim of this study was to compare the eutética mixture of local anesthetic (EMLA) ®, oral glucose solution and acetaminophen in the treatment of acute pain in preterm newborns undergoing arterial puncture , because it is a procedure frequently performed in neonatal intensive care units. The
Conditions
Interventions
Sixty newborns will be studied. They will be randomly distributed into three distinct groups, being group A (20 newborns will receive eutectic mixture of local anesthetics- EMLA, oral glucose placebo,
Drug
Procedure/surgery
D02.065.589.099.750.750.695
Sponsors
Escola de enfermagem da Universidade Federal de Minas Gerais
Hospital das clínicas da Universidade Federal de Minas Gerais
Eligibility
Age
30 Weeks to 35 Weeks
Inclusion criteria
Inclusion criteria: Gestational age above or equal to thirty weeks and less than thirty-five weeks; weight higher than 1500 grams; being admited in the Neonatal Intensive Care Unit of Hospital das Clínicas of Federal University of Minas Gerais; clinical indication of blood collection trough arterial puncture; newborns in the first two weeks of life; minimum enteral diet of sixty mL/Kg per day; parents or guardians signature on the Informed Consent Form and on the image use authorization term.
Exclusion criteria
Exclusion criteria: Clinical diagnosis of neuromuscular dysfunction;Use of analgesia and / or bolus sedation or continuous infusion in the last 48 hours before the procedure;Newborns born to mothers who use illicit drugs;Diagnosis of necrotizing enterocolitis;Newborns under mechanical ventilation;Presence of skin lesion at puncture sites;Treatment with agents that induce methemoglobinemia such as sulfonamides, acetaminophen, phenobarbital, phenytoin and nitric oxide;Patients with hepatic impairment or bleeding;Patients with hemodynamic instabilityNeed of puncture in different places of the place previously selected for application of topical anesthetic;Need for more than three puncture attempts.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Twenty newborns will be evaluated in each group, thus totaling 60 patients. The sample should show a difference of five points in the PIPP scale between the three treatment groups. A sample of 17 patients in each group will be necessary considering a sample power of 90% (beta 10%) and a degree of statistical significance ( alpha) of 5% to detect a difference greater than or equal to 25% in the PIPP scores. | — |
Secondary
| Measure | Time frame |
|---|---|
| To detect changes in heart rate and oxygen saturation, to measure crying time during the intervention, to apply inter-rater correlation tests and to evaluate the adverse effects of the proposed interventions. The Kruskal-Wallis test aims to make a comparison between independent groups, The Friedman test, used to compare medians from paired groups of measures and test, Wilcoxon used for multiple comparisons. The Spearman correlation coefficient is used to determine a correlation between a PIIP and the physiological parameters. | — |
Countries
Brazil
Contacts
Public ContactJuliana Marcatto
Escola de enfermagem da Universidade Federal de Minas Gerais
Outcome results
None listed