Clinical trial NCT01802086: Emla-Cream as Pain Relief During Pneumococcal Vaccination
Official title: Emla-Cream as Pain Relief During Pneumococcal Vaccination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children
Pain
Keywords: Children
Pain
Vaccination
Emla
Pneumococcal
Painscale
Lead sponsor: Sormland County Council, Sweden
Sponsor class: OTHER
First posted: 2013-03-01
Enrollment: 72
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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?

Detailed description: 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 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?

Method: The study is randomised and singleblind. The study involves 72 children who are 3 months old. 36 children will receive Emla-cream and 36 children will receive placebo-cream.

This study will lead to new knowledge about Emla cream and pneumococcal vaccination. The study will give new knowledge how painful pneumococcal vaccination is for the children. If the study shows that Emla cream don´t give enough pain relief during pneumococcal vaccination more studies should be done with other pain relief.

Eligibility criteria: Inclusion Criteria:

* Healthy children, born vaginally or by cesarean section after 37 weeks of gestation, who were not admitted to the neonatal unit. Children should only have been with the PKU testing performed routinely at the hospital.

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.

Primary outcomes:
measure: Measuring the effect of Emla cream on pain perception during pneumococcal vaccination measured with FLACC.
timeFrame: one year
Secondary outcomes:
measure: Pain perception measured with parental perceived VAS, cry-time and pysiological parametical.
timeFrame: one year
Other outcomes:
Locations:
city: Mariefred
country: Sweden
facility: Healthcare center Mariefred/Strängnäs
Study officials:
affiliation: Astrid Lindren Children´s Hospital
name: Marco Bartocci, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: