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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01825655
Other study ID # HM20003779
Secondary ID IIS2012-003
Status Terminated
Phase Phase 4
First received
Last updated
Start date September 2014
Est. completion date November 2017

Study information

Verified date September 2018
Source Virginia Commonwealth University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Terminated
Enrollment 3
Est. completion date November 2017
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Cetirizine

Placebo or sugar pill


Locations

Country Name City State
United States Children's Hospital of Richmond at VCU Richmond Virginia

Sponsors (1)

Lead Sponsor Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline to 3 hours
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