Pruritus
Conditions
Brief summary
The purpose of this study is determine if long acting antihistamine like cetirizine can help with itching induced by opioid pain medications.
Interventions
DRUGCetirizine
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
One other patient consented but did not qualify to begin the study.
Participants by arm
| Arm | Count |
|---|---|
| Cetirizine zyrtec 10mg, oral, one time
Cetirizine | 0 |
| Sugar Pill Placebo, one pill, one time
Placebo or sugar pill | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Cetirizine | Total | Sugar Pill |
|---|---|---|---|
| Age, Customized Between 6 and 21 years | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | — | 2 participants | 2 participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 2 |
| other Total, other adverse events | 0 / 0 | 0 / 2 |
| serious Total, serious adverse events | 0 / 0 | 0 / 2 |
Outcome results
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.
Time frame: Baseline to 3 hours
Population: No participants were randomized into the cetirizine arm
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sugar Pill | Change in Itch Score | 1.5 units on a scale |