Study of Using Long Acting Antihistamine to Treat Opioid Induced Itching

Pruritus Clinical Trial

Official title:

Effect of Long Acting Antihistamine on Opioid- Induced Pruritus: A Double-blind Placebo Controlled Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01825655
• Other study ID #: HM20003779
• Secondary ID: IIS2012-003
• Status: Terminated
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Pruritus

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