Study of Using Long Acting Antihistamine to Treat Opioid Induced Itching

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-11-30

Brief Summary

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

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Detailed Description

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Conditions

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Pruritus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cetirizine

zyrtec 10mg, oral, one time

Group Type ACTIVE_COMPARATOR

Cetirizine

Intervention Type DRUG

Sugar pill

Placebo, one pill, one time

Group Type PLACEBO_COMPARATOR

Placebo or sugar pill

Intervention Type DRUG

Interventions

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Cetirizine

Intervention Type DRUG

Placebo or sugar pill

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No