CompletedNot Applicable

Emla-Cream as Pain Relief During Pneumococcal Vaccination

Sweden72 participantsStarted 2013-05

Plain-language 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 five items; Face, Legs, Activity, Cry, Consolability (FLACC scale) as a pain measurement instrument?

Who can participate

Age range2 Months – 4 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 newborn screening 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 newborn screening. Shoulder dystocia. Children susceptible to methaemoglobinaemia in glucose 6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia. Children with atopic dermatitis.

What they're measuring

Measuring the Effect of Emla Cream on Pain Perception During Pneumococcal Vaccination Measured With Five Items; Face, Legs, Activity, Cry, Consolability (FLACC Scale).

Timeframe: Before vaccination and after vaccination, up to three minutes.

Trial details

NCT IDNCT01802086

SponsorBeatrice Olsson Duse

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-11

Results submitted2023-06-07

View on ClinicalTrials.gov More Children trials