Pain relief with Emla cream during Pneumococcal vaccination.
Conditions
Interventions
Trade Name: Emla cream
Product Name: Emla
Pharmaceutical Form: Cream
INN or Proposed INN: Lidocaine and Prilocaine
Pharmaceutical form of the placebo: Cream
Route of administration of the placebo: Top
Sponsors
Mariefreds Vårdcentral
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy children, normal birth or are born with sectio after 37 weeks of gestation and who are not admitted to the neonatal unit. Children should only have been with the PKU testing performed routinely at the hospital. Are the trial subjects under 18? yes Number of subjects for this age range: 72 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Baby delivered by vacuum extraction or forceps. Children born before gestational week 37. Children in neonatal care and subjected to other testing than PKU. Shoulder dystocia. Children susceptible to methaemoglobinaemia in glucose 6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia. Children with atopic dermatitis because the application time for Emla-plaster should be shortened to 15-30 minutes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Does Emla cream work as pain relief during Pneumococcal vaccination.;Main Objective: The aim of this intervention study is to compare the efficacy of Emla cream as a pain relief or no pain relief in connection to the first pneumococcal vaccination at the age of three months in Child health care. Primary objective 1.Leads Emla cream as pain relief to children in connection with pneumococcal vaccination at the age of three months to lower pain scores in the use of FLACC as a pain measurement instrument? ;Secondary Objective: Secondary objectives 2. Leads Emla cream as pain relief in connection with pneumococcal vaccination to any difference in the child's heart rate response and saturation? 3. Leads Emla cream as pain relief that it takes longer before the baby starts crying and does the child cry for a shorter time in connection with vaccination? 4. Does parents score their child's pain reaction different if the child received Emla cream compared to those who didn´t received any pain relief? | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): This study will lead to new knowledge about Emla cream and pnemocockal vaccination. The study will give new knowledge how painful pneumocockal vaccination is for the children. If the study showes that Emla cream don´t give enough pain relief during pneumocockal vaccination more studies should be done with other pain relief. | — |
Countries
Sweden
Contacts
Public ContactMariefreds Vårdcentral
Mariefreds Vårdcentral
Outcome results
None listed