Phase 4
Completed N=7
Tetracaine Compared to Placebo for Reducing Pain With Palivizumab - A Pilot Study
Source: ClinicalTrials.gov NCT00484393 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcomePrimary: To Determine if a Difference in Pain Scale Ratings is Detectable Following Intramuscular Palivizumab Injection That Was Pre-treated With Placebo or Tetracaine. — 7.3; 7.3; 1.7; 1.6 units on a scale
Summary
This is a small study known as a pilot study. This pilot study is being done to see if a difference in pain from intramuscular palivizumab injection can be detected if tetracaine a topical numbing gel is used compared to no medication (placebo). If a difference is found in this pilot study, then a larger study may be done to confirm that there is a difference in pain experience.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Determine if a Difference in Pain Scale Ratings is Detectable Following Intramuscular Palivizumab Injection That Was Pre-treated With Placebo or Tetracaine. |
7.3; 7.3; 1.7; 1.6; 8.4; 9.3 | — |
Eligibility Criteria
Inclusion Criteria
- Infants between 1 month and 2 years of age receiving palivizumab at Surrey Memorial Hospital for 2 consecutive intramuscular injections during the 2007/8 season
- Parents need to complete informed consent.
Exclusion Criteria
- Allergy/sensitivity to tetracaine, or ester type anaesthetics.
- Infants who present with fever or illness that prevent administration of palivizumab.
Data sourced from ClinicalTrials.gov (NCT00484393). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.