Study of Using Long Acting Antihistamine to Treat Opioid Induced Itching

September 11, 2018 updated by: Virginia Commonwealth University

Effect of Long Acting Antihistamine on Opioid- Induced Pruritus: A Double-blind Placebo Controlled Study

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Children's Hospital of Richmond at VCU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Investigators

  • Principal Investigator: Santhosh Kumar, M.D., Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

March 28, 2013

First Submitted That Met QC Criteria

April 4, 2013

First Posted (Estimate)

April 5, 2013

Study Record Updates

Last Update Posted (Actual)

October 10, 2018

Last Update Submitted That Met QC Criteria

September 11, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM20003779
  • IIS2012-003 (Other Identifier: Virginia Commonwealth University)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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