A Test of the Effectiveness of a Device for Pediatric Immunization Pain
This trial is active, not recruiting.
|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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
|Primary purpose||supportive care|
FLACC observational pain/distress scale
time frame: 5 minutes
Self report using Faces Pain Scale - Revised
time frame: 1 minute after immunizations are complete
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.
|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.|
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