Emla-Cream as Pain Relief During Pneumococcal Vaccination

Condition(s) targeted: Children; Pain

Intervention: Emla-cream (Drug); Miniderm cream (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Beatrice Olsson Duse

Official(s) and/or principal investigator(s):
Marco Bartocci, MD, PhD, Principal Investigator, Affiliation: Astrid Lindren Children´s Hospital

Overall contact:
Marco Bartocci, MD, PhD, Phone: +46703389685, Email: marco.bartocci@ki.se

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?

Official title: Emla-Cream as Pain Relief During Pneumococcal Vaccination

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Primary outcome: Measuring the effect of Emla cream on pain perception during pneumococcal vaccination measured with FLACC.

Secondary outcome: Pain perception measured with parental perceived VAS, cry-time and pysiological parametical.

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.

Minimum age: 2 Months. Maximum age: 4 Months. Gender(s): Both.

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.

Marco Bartocci, MD, PhD, Phone: +46703389685, Email: marco.bartocci@ki.se

Healthcare center Mariefred/Strängnäs, Mariefred 64723, Sweden; Recruiting

Starting date: May 2013
Last updated: April 30, 2015