Emla-Cream as Pain Relief During Pneumococcal Vaccination

B

Beatrice Olsson Duse

Status

Completed

Conditions

Children
Pain

Treatments

Drug: Miniderm cream
Drug: Emla-cream

Study type

Interventional

Funder types

Other

Identifiers

NCT01802086
SormlandCC
2010-021406-38 (EudraCT Number)

Details and patient eligibility

About

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?

Full 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 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 Leads Emla cream as pain relief in connection with pneumococcal vaccination to any difference in the child's heart rate response and saturation? 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.

Enrollment

72 patients

Sex

All

Ages

2 to 4 months old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

72 participants in 2 patient groups, including a placebo group

Emla-cream
Active Comparator group
Description:
Dose: 1 g Emla-cream, 1 hour.
Treatment:
Drug: Emla-cream
Miniderm cream
Placebo Comparator group
Description:
Dose: 1 g Miniderm-cream, 1 hour.
Treatment:
Drug: Miniderm cream

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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