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

Sponsor:	Fraser Health
Information provided by:	Fraser Health
ClinicalTrials.gov Identifier:	NCT00484393

Purpose

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 From Intramuscular Palivizumab Injection	Drug: tetracaine 4% gel	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double-Blind 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:

Drug Information available for: Viractin Tetracaine Palivizumab

U.S. FDA Resources

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 ]

Secondary Outcome Measures:

Adverse effects associated with tetracaine. [ Time Frame: 2 visits, 1 month apart ]

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)

Show Detailed Description

Eligibility

Ages Eligible for Study:	1 Month to 2 Years
Genders Eligible for Study:	Both
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.

Contacts and Locations

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

More Information

Publications:

Young KD. Pediatric procedural pain. Ann Emerg Med. 2005 Feb;45(2):160-71. Review.

Anand KJ, Hickey PR. Pain and its effects in the human neonate and fetus. N Engl J Med. 1987 Nov 19;317(21):1321-9. Review. No abstract available.

Weisman SJ, Bernstein B, Schechter NL. Consequences of inadequate analgesia during painful procedures in children. Arch Pediatr Adolesc Med. 1998 Feb;152(2):147-9.

Jacobson RM, Swan A, Adegbenro A, Ludington SL, Wollan PC, Poland GA; Vaccine Research Group. Making vaccines more acceptable--methods to prevent and minimize pain and other common adverse events associated with vaccines. Vaccine. 2001 Mar 21;19(17-19):2418-27. Review.

Meyerhoff AS, Weniger BG, Jacobs RJ. Economic value to parents of reducing the pain and emotional distress of childhood vaccine injections. Pediatr Infect Dis J. 2001 Nov;20(11 Suppl):S57-62.

O'Brien L, Taddio A, Ipp M, Goldbach M, Koren G. Topical 4% amethocaine gel reduces the pain of subcutaneous measles-mumps-rubella vaccination. Pediatrics. 2004 Dec;114(6):e720-4.

Halperin BA, Halperin SA, McGrath P, Smith B, Houston T. Use of lidocaine-prilocaine patch to decrease intramuscular injection pain does not adversely affect the antibody response to diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b conjugate and hepatitis B vaccines in infants from birth to six months of age. Pediatr Infect Dis J. 2002 May;21(5):399-405.

Zempsky WT, Schechter NL. IMpact-RSV Study Group report. Pediatrics. 1999 Oct;104(4 Pt 1):993-4; author reply 995. No abstract available.

Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.

Responsible Party:	BNewby, Pharmacist, Fraser Health
ClinicalTrials.gov Identifier:	NCT00484393 History of Changes
Other Study ID Numbers:	2007-041
Study First Received:	June 6, 2007
Last Updated:	May 27, 2008
Health Authority:	Canada: Ethics Review Committee

Additional relevant MeSH terms:

Tetracaine
Palivizumab
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions

Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on February 12, 2012