Study of Using Long Acting Antihistamine to Treat Opioid Induced Itching

Phase 4

Terminated

• Conditions: Pruritus
• Interventions: Drug: Placebo or sugar pill; Drug: Cetirizine

• Registration Number: NCT01825655
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-28
• Study First Submitted QC: 2013-04-04
• Study First Posted: 2013-04-05
• Study Start: 2014-09
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Results First Submitted: 2018-08-14
• Results First Submitted QC: 2018-08-14
• Status Verified: 2018-09
• Results First Posted: 2018-09-11
• Last Update Submitted: 2018-09-11
• Last Update Posted: 2018-10-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugar pill	Placebo or sugar pill	Placebo, one pill, one time
Cetirizine	Cetirizine	zyrtec 10mg, oral, one time

Primary Outcome Measures

Name	Time	Method
Change in Itch Score	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.

Trial Locations

Locations (1)

Children's Hospital of Richmond at VCU; 🇺🇸 Richmond, Virginia, United States