Emla-Cream as Pain Relief During Pneumococcal Vaccination

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?

Study Overview

• Status: Completed
• Conditions: Pain; Children
• Intervention / Treatment: Drug: Emla-cream; Drug: Miniderm cream

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

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 scale 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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Mariefred, Sweden, 64723
    • Healthcare center Mariefred/Strängnäs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 4 months (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Emla-cream; Dose: 1 g Emla-cream, 1 hour.	Drug: Emla-cream; Topical anaesthetic; Other Names: Studied drug: Emla-Cream, lidocaine and prilocaine
Placebo Comparator: Miniderm cream; Dose: 1 g Miniderm-cream, 1 hour.	Drug: Miniderm cream; Topical; Other Names: Placebo: Miniderm cream containing 20 % glycerol, non-pharmacological agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Before vaccination and after vaccination, up to three minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	Before vaccination and after vaccination, up to three minutes

Collaborators and Investigators

• Sponsor: Beatrice Olsson Duse
• Investigators: Principal Investigator: Marco Bartocci, MD, PhD, Astrid Lindren Children´s Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: October 31, 2012
• First Submitted That Met QC Criteria: February 27, 2013
• First Posted (Estimated): March 1, 2013

Study Record Updates

• Last Update Posted (Estimated): October 23, 2025
• Last Update Submitted That Met QC Criteria: October 8, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Pain; Children; Vaccination; Pain scale; Emla; Pneumococcal
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Organic Chemicals; Pharmaceutical Preparations; Carbohydrates; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Alcohols; Drug Combinations; Triose Sugar Alcohols; Sugar Alcohols; Lidocaine, Prilocaine Drug Combination; Lidocaine; Glycerol; Prilocaine
• Other Study ID Numbers: SormlandCC; 2010-021406-38 (EudraCT Number)