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Study of Using Long Acting Antihistamine to Treat Opioid Induced Itching

This study is currently recruiting participants.
See Contacts and Locations
Verified December 2016 by Virginia Commonwealth University
Information provided by (Responsible Party):
Virginia Commonwealth University Identifier:
First received: March 28, 2013
Last updated: December 6, 2016
Last verified: December 2016
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


Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01825655

Contact: Santhosh Kumar, MD 804-628-1605

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

Responsible Party: Virginia Commonwealth University Identifier: NCT01825655     History of Changes
Other Study ID Numbers: IIS2012-003
Study First Received: March 28, 2013
Last Updated: December 6, 2016

Additional relevant MeSH terms:
Skin Diseases
Skin Manifestations
Signs and Symptoms
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 processed this record on September 20, 2017