Study of Using Long Acting Antihistamine to Treat Opioid Induced Itching

This study is not yet open for participant recruitment.
Verified January 2014 by Virginia Commonwealth University
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01825655
First received: March 28, 2013
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

The purpose of this study is determine if long acting antihistamine like zyrtec can help with itching induced by opioid pain medications.


Condition Intervention Phase
Pruritus
Drug: Cetirizine
Drug: Placebo or sugar pill
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Long Acting Antihistamine on Opioid- Induced Pruritus: A Double-blind Placebo Controlled Study

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Itch score [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    Itch score will be used to analyze our primary outcome. The subjects will have an itch score at baseline and compared to itch score at 3hrs post intervention.


Estimated Enrollment: 73
Study Start Date: March 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cetirizine
zyrtec 10mg, oral, one time
Drug: Cetirizine
Placebo Comparator: Sugar pill
Placebo, one pill, one time
Drug: Placebo or sugar pill

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children age 6-18yrs on opioids who develop pruritus and are willing to participate in the study

Exclusion Criteria:

  • Children with history of chronic urticaria
  • Children with other chronic pruritic condition like eczema, contact dermatitis, psoriasis
  • Children with known hypersensitivity to cetirizine
  • Children on second generation antihistamine 1 week prior to the study recruitment
  • Children who are unwilling or unable to swallow the capsule
  • Children with chronic liver or kidney disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01825655

Contacts
Contact: Santhosh Kumar, MD 804-628-1605 skumar@vcu.edu

Locations
United States, Virginia
Children's Hospital of Richmond at VCU Not yet recruiting
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Santhosh Kumar, M.D. Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01825655     History of Changes
Other Study ID Numbers: IIS2012-003
Study First Received: March 28, 2013
Last Updated: January 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pruritus
Skin Diseases
Skin Manifestations
Signs and Symptoms
Histamine Antagonists
Cetirizine
Histamine H1 Antagonists
Analgesics, Opioid
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Allergic Agents
Therapeutic Uses
Histamine H1 Antagonists, Non-Sedating
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on April 17, 2014