This trial is active, not recruiting.

Condition pain
Treatment buzzy
Sponsor MMJ Labs LLC
Collaborator Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Start date January 2009
End date June 2009
Trial size 60 participants
Trial identifier NCT00910611, 08-028, 1R44HD056647-01A2


A vibrating cold pack placed proximal to the site of immunization will decrease the pain of routine preschool immunizations when compared to standard care.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose supportive care
(No Intervention)
Immunizations given with standard care of no pain control
Vibrating device with cold pack held to arm proximal to injections
buzzy Buzzy R
"Buzzy", the vibrating cold pack, is pressed by parent or nurse immediately prior to immunizations. The vibration is activated and the device remains in place throughout the procedure, moving locations to complete the 4 shots.

Primary Outcomes

FLACC observational pain/distress scale
time frame: 5 minutes

Secondary Outcomes

Self report using Faces Pain Scale - Revised
time frame: 1 minute after immunizations are complete

Eligibility Criteria

Male or female participants from 4 years up to 6 years old.

Inclusion Criteria: - Patients receiving standard preschool immunizations - Informed consent Exclusion Criteria: - Clear cognitive impairments affecting communication - Chronic illness requiring frequent injections - Patients with sickle cell or other sensitivity to cold - Patients who have received more than two immunizations on the same visit within the past two years.

Additional Information

Official title Relieving Pediatric Immunization Pain Using A Reusable Personal Device
Principal investigator Amy L Baxter, MD
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 provides analgesia 6% of the time. An inexpensive, immediately acting form of needle pain control could reduce needle phobia or vaccine refusal in the long term if demonstrated to be effective for immunization pain. This study will evaluate pain responses using video-coded FLACC scores for patients undergoing routine pre-school immunizations. Parent and patient pain assessments, as well as demographic information and pre-procedural anxiety coded from videos will be included.
Trial information was received from ClinicalTrials.gov and was last updated in June 2010.
Information provided to ClinicalTrials.gov by MMJ Labs LLC.