Study of Using Long Acting Antihistamine to Treat Opioid Induced Itching

Virginia Commonwealth University (VCU)

Status and phase: Terminated; Phase 4

Conditions: Pruritus

Treatments: Drug: Cetirizine; Drug: Placebo or sugar pill

Study type: Interventional

Funder types: Other

Identifiers

NCT01825655

HM20003779

IIS2012-003 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 3 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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3 participants in 2 patient groups, including a placebo group

Cetirizine

Active Comparator group

Description:

zyrtec 10mg, oral, one time

Treatment:

Drug: Cetirizine

Sugar pill

Placebo Comparator group

Description:

Placebo, one pill, one time

Treatment:

Drug: Placebo or sugar pill