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Study of Using Long Acting Antihistamine to Treat Opioid Induced Itching

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01825655
Recruitment Status : Terminated (Unable to recruit patients)
First Posted : April 5, 2013
Results First Posted : September 11, 2018
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Description
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Brief Summary:
The purpose of this study is determine if long acting antihistamine like cetirizine can help with itching induced by opioid pain medications.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
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
Study Start Date : September 2014
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Cetirizine
zyrtec 10mg, oral, one time
 Drug: Cetirizine
Placebo Comparator: Sugar pill
Placebo, one pill, one time
 Drug: Placebo or sugar pill


Outcome Measures
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Primary Outcome Measures :
  1. Change in Itch Score [ Time Frame: Baseline to 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. Itch score is measured on a scale of 1 to 4, with lower scores indicating less itchiness.


Eligibility Criteria
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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
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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


Locations
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United States, Virginia
Children's Hospital of Richmond at VCU
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Santhosh Kumar, M.D. Virginia Commonwealth University
  Study Documents (Full-Text)

Documents provided by Virginia Commonwealth University:
Study Protocol and Statistical Analysis Plan  [PDF] August 26, 2015

More Information
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01825655    
Other Study ID Numbers: HM20003779
IIS2012-003 ( Other Identifier: Virginia Commonwealth University )
First Posted: April 5, 2013    Key Record Dates
Results First Posted: September 11, 2018
Last Update Posted: October 10, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Pruritus
Skin Diseases
Skin Manifestations
Cetirizine
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
 Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs