Emla-Cream as Pain Relief During Pneumococcal Vaccination

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Sormland County Council, Sweden
Sponsor:
Information provided by (Responsible Party):
Beatrice Olsson Duse, Sormland County Council, Sweden
ClinicalTrials.gov Identifier:
NCT01802086
First received: October 31, 2012
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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 as a pain measurement instrument?


Condition Intervention
Children
Pain
Drug: Emla-cream
Drug: Miniderm cream

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Emla-Cream as Pain Relief During Pneumococcal Vaccination

Resource links provided by NLM:


Further study details as provided by Sormland County Council, Sweden:

Primary Outcome Measures:
  • Measuring the effect of Emla cream on pain perception during pneumococcal vaccination measured with FLACC. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Score of FLACC-points.


Secondary Outcome Measures:
  • Pain perception measured with parental perceived VAS, cry-time and pysiological parametical. [ Time Frame: one year ] [ Designated as safety issue: Yes ]

    VAS-units

    Cry-time: how long does it takes until the baby starts to cry and for how long time is the baby crying.

    Heartbeat/minute

    Saturation/minute



Estimated Enrollment: 72
Study Start Date: May 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Emla-cream
Dose: 1 g Emla-cream, 1 hour.
Drug: Emla-cream
Topical anaesthetic
Other Name: Studied drug: Emla-Cream, lidocaine and prilocaine
Placebo Comparator: Miniderm cream
Dose: 1 g Miniderm-cream, 1 hour.
Drug: Miniderm cream
Topical
Other Name: Placebo:Miniderm, glycerin cream, non-pharmacological agent

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 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.

  Eligibility

Ages Eligible for Study:   2 Months to 4 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 PKU testing 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 PKU. Shoulder dystocia. Children susceptible to methaemoglobinaemia in glucose 6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia. Children with atopic dermatitis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01802086

Contacts
Contact: Marco Bartocci, MD, PhD +46703389685 marco.bartocci@ki.se
Contact: Beatrice Olsson Duse, Spec. nurse +46159 29012 beatrice.olsson-duse@karolinska.se

Locations
Sweden
Healthcare center Mariefred/Strängnäs Recruiting
Mariefred, Sweden, 64723
Sponsors and Collaborators
Beatrice Olsson Duse
Investigators
Principal Investigator: Marco Bartocci, MD, PhD Astrid Lindren Children´s Hospital
  More Information

No publications provided

Responsible Party: Beatrice Olsson Duse, RN, Sormland County Council, Sweden
ClinicalTrials.gov Identifier: NCT01802086     History of Changes
Other Study ID Numbers: SormlandCC, 2010-021406-38
Study First Received: October 31, 2012
Last Updated: June 2, 2014
Health Authority: United States: Food and Drug Administration
Sweden: Regional Ethical Review Board

Keywords provided by Sormland County Council, Sweden:
Children
Pain
Vaccination
Emla
Pneumococcal
Painscale

Additional relevant MeSH terms:
Prilocaine
EMLA
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Combined
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014