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Study of Using Long Acting Antihistamine to Treat Opioid Induced Itching

Primary Purpose

Pruritus

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Cetirizine
Placebo or sugar pill
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pruritus

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of Richmond at VCU

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Cetirizine

Sugar pill

Arm Description

zyrtec 10mg, oral, one time

Placebo, one pill, one time

Outcomes

Primary Outcome Measures

Change in Itch Score
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.

Secondary Outcome Measures

Full Information

First Posted
March 28, 2013
Last Updated
September 11, 2018
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT01825655
Brief Title
Study of Using Long Acting Antihistamine to Treat Opioid Induced Itching
Official Title
Effect of Long Acting Antihistamine on Opioid- Induced Pruritus: A Double-blind Placebo Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit patients
Study Start Date
September 2014 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cetirizine
Arm Type
Active Comparator
Arm Description
zyrtec 10mg, oral, one time
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
Placebo, one pill, one time
Intervention Type
Drug
Intervention Name(s)
Cetirizine
Intervention Type
Drug
Intervention Name(s)
Placebo or sugar pill
Primary Outcome Measure Information:
Title
Change in Itch Score
Description
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.
Time Frame
Baseline to 3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Santhosh Kumar, M.D.
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Richmond at VCU
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of Using Long Acting Antihistamine to Treat Opioid Induced Itching

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