Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06624176
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-02
Brief Title:
ShotBlocker During Intramuscular Injection Randomized Control Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of ShotBlocker on Pain in Full Term Infants Undergoing Intramuscular Injection a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this trial is to evaluate the effect of Bionix ShotBlocker on pain of injection of the first Hepatitis B vaccine in healthy newborns ShotBlocker is a pain reducing tool used in babies children and adults for injections Swaddling during the injection and administration of oral sucrose prior to the injection are established standards of care for painful procedures in neonates The investigators hypothesize that the use of ShotBlocker in addition to swaddling and oral sucrose administration will lessen the pain response
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None