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ShotBlocker During Intramuscular Injection Randomized Control Trial

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 4, 2026 (before its estimated September 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion pushed from May 1, 2026 to Sep 1, 2026
    • Study completion pushed from Aug 1, 2026 to Oct 1, 2026
    v5
  2. Primary completion date: Dec 15, 2025 to May 1, 2026
    • Study completion date: Mar 15, 2026 to Aug 1, 2026
    v4
  3. Primary completion date: Jul 15, 2025 to Dec 15, 2025
    • Study completion date: Sep 15, 2025 to Mar 15, 2026
    v3
  4. Primary completion date: Mar 15, 2025 to Jul 15, 2025
    • Study completion date: Apr 15, 2025 to Sep 15, 2025
    • Site contact updated
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06624176
Lead Sponsor Lauren Fortier
Conditions
(from sponsor)		 Neonatal Pain
Related terms Needlestick Injuries
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov