Emla-Cream as Pain Relief During Pneumococcal Vaccination

NCT01802086 | Completed Results DMC

• 2 other identifiers: SormlandCC2010-021406-38
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Children; Pain

Keywords

Children; Pain; Vaccination; Emla; Pneumococcal; Pain scale

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pain Perception Measured With Latency Time to Cry and Total Crying Time.

  Before vaccination and after vaccination, up to three minutes.

• Heart Rate (Beats Per Minute) Before and After Vaccination

  Before vaccination and after vaccination, up to three minutes

• Saturation Before and After Vaccination.

  Before vaccination and after vaccination, up to three minutes

Study Arms (2)

Emla-cream

ACTIVE COMPARATOR

Dose: 1 g Emla-cream, 1 hour.

Drug: Emla-cream

Miniderm cream

PLACEBO COMPARATOR

Dose: 1 g Miniderm-cream, 1 hour.

Drug: Miniderm cream

Interventions

Emla-cream DRUG

Topical anaesthetic

Also known as: Studied drug: Emla-Cream, lidocaine and prilocaine

Emla-cream

Miniderm cream DRUG

Topical

Also known as: Placebo: Miniderm cream containing 20 % glycerol, non-pharmacological agent

Miniderm cream

Eligibility Criteria

• Age: 2 Months - 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beatrice Olsson Duse: lead

Study Sites (1)

Healthcare center Mariefred/Strängnäs

Mariefred, 64723, Sweden

Location

MeSH Terms

Conditions

Pain

Interventions

Lidocaine, Prilocaine Drug Combination; Lidocaine; Prilocaine; Glycerol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations; Triose Sugar Alcohols; Sugar Alcohols; Alcohols; Carbohydrates

Results Point of Contact

• Title: Beatrice Olsson Duse
• Organization: SormlandCC

bod257@hotmail.com

0704948359

Study Officials

• Marco Bartocci, MD, PhD

  Astrid Lindren Children´s Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: RN

Study Record Dates

• First Submitted: October 31, 2012
• First Posted: March 1, 2013
• Study Start: May 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: October 23, 2025
• Results First Posted: October 23, 2025

Record last verified: 2025-10

Locations

SE (1)