drugset / Trial / NCT00267111
Topical Amethocaine Gel for Intramuscular Injection in Term Neonates
Phase 2
Completed
110 enrolled
Mount Sinai Hospital, Canada
Striving for Excellence Fund, Mount Sinai Hospital · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study will examine the efficacy of topical amethocaine gel (Ametop) in decreasing the pain response in term neonates subjected to intramuscular injection for administration of vitamin K. Study Hypothesis: We believe that topical amethocaine gel will be superior to placebo in decreasing the pain from intramuscular injection in term neonates.
Timeline
- Start
- 2003-07
- Primary completion
- 2004-12
- Completion
- 2004-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | tetracaine | Other / unclassified | 1 g | Topical |
Indications
No indication recorded.