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

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ClinicalTrials.gov Identifier: NCT00484393
Recruitment Status : Completed
First Posted : June 8, 2007
Results First Posted : March 18, 2015
Last Update Posted : June 19, 2015
Sponsor:
Information provided by (Responsible Party):
Brandi Newby, Fraser Health

Brief 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.

Condition or disease Intervention/treatment Phase
Pain Drug: tetracaine 4% gel Drug: Placebo Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
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
Study Start Date : November 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   1 Month to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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


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

Publications:
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 Posted: June 8, 2007    Key Record Dates
Results First Posted: March 18, 2015
Last Update Posted: June 19, 2015
Last Verified: May 2015

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