Phase 4 N=7 Randomized Triple-blind Supportive Care

Tetracaine Compared to Placebo for Reducing Pain With Palivizumab - A Pilot Study

Pain

Bottom Line

View on ClinicalTrials.gov: NCT00484393 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2015

Primary outcome: 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 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: tetracaine 4% gel (Drug); Placebo (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Fraser Health
Primary completion: Apr 2008

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	—

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.

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.

View full record on ClinicalTrials.gov →

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.