N/A
Completed N=72
Emla-Cream as Pain Relief During Pneumococcal Vaccination
Children · Postoperative Pain
Source: ClinicalTrials.gov NCT01802086 ↗
Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcomePrimary: Measuring the Effect of Emla Cream on Pain Perception During Pneumococcal Vaccination Measured With Five Items; Face, Legs, Activity, Cry, Consolability (FLACC Scale). — 0; 0; 7; 9 score on a scale
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?
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measuring the Effect of Emla Cream on Pain Perception During Pneumococcal Vaccination Measured With Five Items; Face, Legs, Activity, Cry, Consolability (FLACC Scale). |
0; 0; 7; 9 | — |
| SECONDARY Pain Perception Measured With Latency Time to Cry and Total Crying Time. |
2.77; 2.05; 78.74; 100.44 | — |
| SECONDARY Heart Rate (Beats Per Minute) Before and After Vaccination |
148.31; 147.93; 159.59; 160.46 | — |
| SECONDARY Saturation Before and After Vaccination. |
99.59; 99.78; 98.86; 98.76 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT01802086). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.