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Study of Using Long Acting Antihistamine to Treat Opioid Induced Itching

This study is currently recruiting participants.
Verified December 2016 by Virginia Commonwealth University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01825655
First Posted: April 5, 2013
Last Update Posted: December 8, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Virginia Commonwealth University
  Purpose
The purpose of this study is determine if long acting antihistamine like cetirizine 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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 ]
    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: September 2014
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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/zyrtec
  • Children on H1 antihistamine like diphenhydramine, hydroxyzine, cetirizine, loratadine, fexofenadine, chlorpheniramine within the last 7days prior to randomization
  • Children who have received Ondansetron within 24hrs prior to randomization
  • Children who are on Tricyclic antidepressants
  • Children who are unwilling or unable to swallow the capsule.
  • Children with chronic liver or kidney disease
  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): NCT01825655


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

Locations
United States, Virginia
Children's Hospital of Richmond at VCU Recruiting
Richmond, Virginia, United States, 23298
Contact: santhosh kumar, MD    804-628-1605    skumar@vcu.edu   
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Santhosh Kumar, M.D. Virginia Commonwealth University
  More Information

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01825655     History of Changes
Other Study ID Numbers: IIS2012-003
First Submitted: March 28, 2013
First Posted: April 5, 2013
Last Update Posted: December 8, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Pruritus
Skin Diseases
Skin Manifestations
Signs and Symptoms
Cetirizine
Histamine Antagonists
Histamine H1 Antagonists
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs