A Test of the Effectiveness of a Device and Distraction for Pediatric Immunization Pain

MMJ Labs

Status and phase: Completed; Phase 3; Phase 2

Conditions: Procedural Pain

Treatments: Device: Buzzy: sham device; Device: Device: Buzzy

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT01152489

H09501

R44HD056647-01A2 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The hypothesis of this study is that distraction cards used by the caretaker along with a vibrating cold pack placed proximal to the site of immunization will decrease the pain of routine pediatric immunizations when compared to a placebo device or standard care.

Full description

Needle pain is the most common and the most feared source of childhood pain, resulting in needle phobia for 10$ of adults. Current standard of care for immunizations in the US is no pain relief. An inexpensive, immediately effective form of needle pain control could reduce needle phobia or vaccine refusal in the long term if demonstrated to be effective for immunization pain.

Distraction can decrease procedural distress in children by 50%. The effect of using a multi-modal pain and distraction relieving approach has not been rigorously studied.

Enrollment: 345 estimated patients

Sex: All

Ages: 4 months to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• children receiving routine immunizations

Exclusion criteria

• no caregiver present
• chronic illness requiring frequent injections
• clear cognitive impairments affecting communication

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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345 participants in 3 patient groups

Standard Care

No Intervention group

Description:

Immunizations are given with standard care of no pain control

Experimental

Active Comparator group

Description:

Vibrating device with cold pack held to arm proximal to injections within the same dermatome; caretakers offered and instructed in use of distraction cards.

Treatment:

Device: Device: Buzzy

Sham Device

Sham Comparator group

Description:

The device without batteries or cold pack held to arm proximal to injections. No formal distraction.

Treatment:

Device: Buzzy: sham device