Role of Nefopam in Rituximab Transfusion Reaction

Phase 3

Not yet recruiting

• Conditions: Nefopam
• Interventions: Drug: diphenhydramine ampule; Drug: Nefopam ampule

• Registration Number: NCT05648058
• Lead Sponsor: Ministry Of Health / Nineveh Health Directorate

Brief Summary

the patients will be taken nefopam ampule 50 mg before rituximab in the first group while the second group will be taken diphenhydramine ampule 10 mg before rituximab in the second group

Detailed Description

the two groups will be taken standard therapy (hydrocortisone vial 100 mg and acetaminophen 1000 mg) 30 min before rituximab

Study Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-04
• Study First Submitted QC: 2022-12-04
• Study First Posted: 2022-12-13
• Last Update Submitted: 2022-12-13
• Last Update Posted: 2022-12-15
• Study Start: 2022-12-20
• Primary Completion: 2023-10-20
• Study Completion: 2023-11-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 18 - 80 years old male and female will be taken rituximab

Exclusion Criteria

• less than 18 years old more than 80 years old diabetic patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
diphenhydramine	diphenhydramine ampule	administration of intravenous diphenhydramine to prevent Rituximab Transfusion Reaction
nefopam	Nefopam ampule	administration of intravenous nefopam to prevent Rituximab Transfusion Reaction

Primary Outcome Measures

Name	Time	Method
transfusion reaction	30 min	fever, riger, rash, chills, pruritus and bronchospasm