Reduction of Immunization Discomfort in Children | NCT00720824

Studies
Reduction of Immunization Discomfort in Children

NCT00720824

Sponsor

Berberich, F. Ralph, M.D.

Status

Completed

Last Update Posted

Jul 23, 2008Estimated

Enrollment

42Actual

Phase

Not Applicable

Conditions

Pain

Interventions

Topical anesthetic and hypnotic distraction
Office routine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Aug 2007Actual

Completion Date

Aug 2007Actual

First Submitted Date

Jul 21, 2008

First Submission Date that Met QC Criteria

Jul 22, 2008

First Posted Date

Jul 23, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2008

Last Update Posted Date

Jul 23, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A combination of topical anesthetic, plastic arm gripper, visual focusing task and hypnotic suggestions will reduce the discomfort associated with immunization of pre-kindergarten aged children.

Detailed Description

Randomization of 42 children evaluated the method described above against an office routine control group.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Ethyl chloride spray, plastic arm gripper, vibrating instrument, hypnotic suggestions	Behavioral: Topical anesthetic and hypnotic distraction
2	Placebo Comparator	Office routine	Behavioral: Office routine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Topical anesthetic and hypnotic distraction	Behavioral	Ethyl chloride spray, plastic arm gripper, vibrating instrument, hypnotic suggestions.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Facial Pain Scale and Faces-Legs-Activity-Cry-Consolability Scale measurements of degree of discomfort.		10 Minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All children ages 4-6 years scheduled to receive routine pre-kindergarten immunizations

Exclusion Criteria:

Inability to follow verbal directions
Significant concurrent illness
Prior invasive procedures, excluding neonatal circumcision

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
f. Ralph berberich, MD	Pediatric Medial Group	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pediatric Medical Group		Berkeley	California	94705	United States

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000779	Anesthetics, Local

Ancestor Terms

ID	Term
D000777	Anesthetics
D002492	Central Nervous System Depressants
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions

Browse Leaves

Not provided

Browse Branches

Not provided