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

NCT00484393 | Completed Phase 4 Results

• 1 other identifier: 2007-041
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• To Determine if a Difference in Pain Scale Ratings is Detectable Following Intramuscular Palivizumab Injection That Was Pre-treated With Placebo or Tetracaine.

  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

  2 visits, 1 month apart

Study Arms (2)

Tetracaine

EXPERIMENTAL

Tetracaine 4% gel 1g applied to injection site

Drug: tetracaine 4% gel

Placebo

PLACEBO COMPARATOR

Placebo cream (Aquatain) 1g applied to inejction site

Drug: Placebo

Interventions

tetracaine 4% gel DRUG

tetracaine applied prior to 1 injection

Also known as: Ametop

Tetracaine

Placebo DRUG

placebo applied prior to 1 injection

Also known as: Aquatain used as placebo to look like tetracaine

Placebo

Eligibility Criteria

• Age: 1 Month - 2 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Allergy/sensitivity to tetracaine, or ester type anaesthetics.
• Infants who present with fever or illness that prevent administration of palivizumab.

Sponsors & Collaborators

• Fraser Health: lead

Study Sites (1)

Surrey Memorial Hospital

Surrey, British Columbia, V3V1Z2, Canada

Location

Related Publications (9)

• Young KD. Pediatric procedural pain. Ann Emerg Med. 2005 Feb;45(2):160-71. doi: 10.1016/j.annemergmed.2004.09.019.

  PMID: 15671974 BACKGROUND

• 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. doi: 10.1056/NEJM198711193172105. No abstract available.

  PMID: 3317037 BACKGROUND

• 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. doi: 10.1001/archpedi.152.2.147.

  PMID: 9491040 BACKGROUND

• 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. doi: 10.1016/s0264-410x(00)00466-7.

  PMID: 11257372 BACKGROUND

• 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. doi: 10.1097/00006454-200111001-00009.

  PMID: 11704725 BACKGROUND

• 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. doi: 10.1542/peds.2004-0722.

  PMID: 15574604 BACKGROUND

• 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. doi: 10.1097/00006454-200205000-00010.

  PMID: 12150176 BACKGROUND

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

  PMID: 10532865 BACKGROUND

• 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.

  PMID: 9220806 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Tetracaine; Gels

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Brandi Newby
• Organization: Fraser Health

brandi.newby@fraserhealth.ca

604-585-5666

Study Officials

• Brandi D Newby, BScPharm

  Surrey Memorial Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacy Specialist

Study Record Dates

• First Submitted: June 6, 2007
• First Posted: June 8, 2007
• Study Start: November 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: June 19, 2015
• Results First Posted: March 18, 2015

Record last verified: 2015-05

Locations

CA (1)