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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: June 8, 2007
Last Update Posted: June 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Brandi Newby, Fraser Health
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
Pain Drug: tetracaine 4% gel Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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 Brandi Newby, 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 ]
    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

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Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 2 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Suresh G, Zempsky WT, Schechter NL, Fox JL, Connor EM, Carlin D, Top FH, Weisman LE. IMpact-RSV Study Group Report. Pediatrics 1999;104(4):993-5.

Responsible Party: Brandi Newby, Clinical Pharmacy Specialist, Fraser Health
ClinicalTrials.gov Identifier: NCT00484393     History of Changes
Other Study ID Numbers: 2007-041
First Submitted: June 6, 2007
First Posted: June 8, 2007
Results First Submitted: March 5, 2015
Results First Posted: March 18, 2015
Last Update Posted: June 19, 2015
Last Verified: May 2015

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