ChildrenNCT01802086
Emla-Cream as Pain Relief During Pneumococcal Vaccination
A study testing Emla-cream and Miniderm cream in people with Children and Pain, run by Beatrice Olsson Duse at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 2 to 4 months
- What is being tested?
- Emla-cream and Miniderm cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteSweden
- Study dates
- May 2013to Nov 2015
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read the 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
- 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 scale 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.
- Being tested
- Emla-cream, Miniderm cream
- Keywords
- Children, Pain, Vaccination, Emla, Pneumococcal, Pain scale
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emla-creamDrug
Also called Studied drug: Emla-Cream, lidocaine and prilocaine
Topical anaesthetic
Miniderm creamDrug
Also called Placebo: Miniderm cream containing 20 % glycerol, non-pharmacological agent
Topical
| Study group | Role | What they receive |
|---|---|---|
| Emla-cream | Active comparator | Dose: 1 g Emla-cream, 1 hour. Receives: Drug: Emla-cream |
| Miniderm cream | Placebo comparator | Dose: 1 g Miniderm-cream, 1 hour. Receives: Drug: Miniderm cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the Effect of Emla Cream on Pain Perception During Pneumococcal Vaccination Measured With Five Items; Face, Legs, Activity, Cry, Consolability (FLACC Scale).
The effect of Emla cream on pain perception during pneumococcal vaccination was measured by FLACC scale that includes five items; Face, Legs, Activity, Cry, Consolability. FLACC scale i a qualitative behavioural scale used for pain assesment and has been validated for use in infants aged 2 months to 7 years. Each item (Face, Legs, Activity, Cry and Consolability) can give 0,1 or 2 points according to the description included in the FLACC scale. The total summarised pain score can range between 0-10 points. A higher pain-score indicate more pain, which means a worse outcome.
FLACC scale was measured before and after vaccination and compared between the groups (Emla-cream vs Miniderm cream).
Measured: Before vaccination and after vaccination, up to three minutes.
Secondary outcomes (3)
Pain Perception Measured With Latency Time to Cry and Total Crying Time.
Latency time to cry (scored in seconds):
- how long does it takes until the baby starts to cry after vaccination was performed (the longer it takes until the baby starts to cry indicate less pain, a better outcome). Min- or maximum values is not applicable.
Total crying time (scored in seconds):
- how long time is the baby crying after vaccination was performed (the longer time the baby is crying indicate more pain, a worse outcome). Min- or maximum values is not applicable.
Measured: Before vaccination and after vaccination, up to three minutes.
Heart Rate (Beats Per Minute) Before and After Vaccination
Heart rate before and after vaccination (beats per minute), higher values indicate more pain, a worse outcome. Min and max values are not applicable.
Measured: Before vaccination and after vaccination, up to three minutes
Saturation Before and After Vaccination.
Oxygen saturation before and after vaccination (0-100%), a lower value indicate more pain, a worse outcome
Measured: Before vaccination and after vaccination, up to three minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startMay 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beatrice Olsson Duse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Beatrice Olsson Duse, Sormland County Council, Sweden
- Investigators
- Marco Bartocci, MD, PhD, Principal investigator, Astrid Lindren Children´s Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802086
- Sponsor's protocol ID
- SormlandCC
- Other IDs
- 2010-021406-38
- Status last verified
- Oct 2025
- First submitted
- 31 Oct 2012
- Last updated
- 23 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes