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Pilot Study for the Evaluation of the Efficacy of Prophylactic Loratadine on G-CSF and Its Derivatives- Induced Bone Pain in Children undergoing Chemotherapy

Pilot Study for the Evaluation of the Efficacy of Prophylactic Loratadine on G-CSF and Its Derivatives- Induced Bone Pain in Children undergoing Chemotherapy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241213064045N1
Enrollment
30
Registered
2025-01-17
Start date
2025-02-19
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone pain induced by G-CSF and its derivatives in children undergoing chemotherapy.

Interventions

Intervention 1: Intervention group: At least one hour before receiving filgrastim or its derivatives, Loratadine syrup at the dose of 10 mg daily for one week + Acetaminophen PRN ??mg/kg q?h (if neede

Sponsors

Oroumia University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 18 Years

Inclusion criteria

Inclusion criteria: Age 6 to 18 years Undergoing chemotherapy with an indication for receiving pegfilgrastim or filgrastim Parent or legal guardian consent for participation in the study

Exclusion criteria

Exclusion criteria: Any contraindication for receiving loratadine (e.g., previous allergy to the drug) Concurrent use of antihistamines for any reason or patients who have received antihistamines in the past three days Patients with bone pain due to an underlying condition Patients on a stable regimen of opioids or NSAIDs

Design outcomes

Primary

MeasureTime frame
The difference in pain score in the first cycle between the two groups. Timepoint: every 24 hours while receiving the intervention or control treatment. Method of measurement: Visual Analogue Scale.

Secondary

MeasureTime frame
The difference in the number of times painkiller treatment is needed between the two groups. Timepoint: every 24 hours while receiving the intervention or control treatment. Method of measurement: Visual Analogue Scale.;The difference in pain scores in the second cycle between the two groups. Timepoint: every 24 hours while receiving the intervention or control treatment. Method of measurement: Visual Analogue Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Karbasi Kalajahi

Oroumia University of Medical Sciences

Ali.karbasi2002@gmail.com+98 44 3275 4991

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026