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

This study has been completed.
Information provided by (Responsible Party):
Brandi Newby, Fraser Health
ClinicalTrials.gov Identifier:
First received: June 6, 2007
Last updated: May 22, 2015
Last verified: May 2015

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.

Condition Intervention Phase
Drug: tetracaine 4% gel
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Tetracaine (Ametop®) Compared to Placebo for Reducing Pain Associated With Intramuscular Injection of Palivizumab (Synagis®) - A Pilot Study

Resource links provided by NLM:

Further study details as provided by Fraser Health:

Primary Outcome Measures:
  • To Determine if a Difference in Pain Scale Ratings is Detectable Following Intramuscular Palivizumab Injection That Was Pre-treated With Placebo or Tetracaine. [ Time Frame: 2 visits, 1 month apart ] [ Designated as safety issue: No ]
    Parent score 1-10 (1 representing no pain and 10 representing extreme pain) FLACC (Face, Legs, Activity, Cry, Consolability) Score 0-10 (at baseline and post injection) (0 representing no pain and 10 representing extreme pain) Change in FLACC score

Enrollment: 7
Study Start Date: November 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tetracaine
Tetracaine 4% gel 1g applied to injection site
Drug: tetracaine 4% gel
tetracaine applied prior to 1 injection
Other Name: Ametop
Placebo Comparator: Placebo
Placebo cream (Aquatain) 1g applied to inejction site
Drug: Placebo
placebo applied prior to 1 injection
Other Name: Aquatain used as placebo to look like tetracaine

  Show Detailed Description


Ages Eligible for Study:   1 Month to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484393

Canada, British Columbia
Surrey Memorial Hospital
Surrey, British Columbia, Canada, V3V1Z2
Sponsors and Collaborators
Fraser Health
Principal Investigator: Brandi D Newby, BScPharm Surrey Memorial Hospital
  More Information


Responsible Party: Brandi Newby, Clinical Pharmacy Specialist, Fraser Health
ClinicalTrials.gov Identifier: NCT00484393     History of Changes
Other Study ID Numbers: 2007-041
Study First Received: June 6, 2007
Results First Received: March 5, 2015
Last Updated: May 22, 2015
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Anesthetics, Local
Anti-Infective Agents
Antiviral Agents
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 09, 2015