Emla-Cream as Pain Relief During Pneumococcal Vaccination

Pain Clinical Trial

Official title:

Emla-Cream as Pain Relief During Pneumococcal Vaccination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01802086
• Other study ID #: SormlandCC
• Secondary ID: 2010-021406-38
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: November 2015

Study information

• Verified date: December 2021
• Source: Sormland County Council, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 4 Months

Eligibility

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.

Related Conditions & MeSH terms

• Children
• Pain

Intervention

Drug:
• Emla-cream
Topical anaesthetic
• Miniderm cream
Topical

Locations

Country	Name	City	State
Sweden	Healthcare center Mariefred/Strängnäs	Mariefred

Sponsors (1)

Lead Sponsor	Collaborator
Beatrice Olsson Duse

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring the effect of Emla cream on pain perception during pneumococcal vaccination measured with FLACC.	Score of FLACC-points.	one year
Secondary	Pain perception measured with parental perceived VAS, cry-time and pysiological parametical.	VAS-units; Cry-time: how long does it takes until the baby starts to cry and for how long time is the baby crying.; Heartbeat/minute; Saturation/minute	one year