Role of Nefopam in Rituximab Transfusion Reaction

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

Study Overview

• Status: Not yet recruiting
• Conditions: Nefopam
• Intervention / Treatment: Drug: Nefopam ampule; Drug: diphenhydramine ampule

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: fakhraldin marwan; Phone Number: 07817639470; Email: drfakhralin@gmail.com
• Study Contact Backup: Name: zainab thanon; Phone Number: 07518097301; Email: zainabthanon@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nefopam; administration of intravenous nefopam to prevent Rituximab Transfusion Reaction	Drug: Nefopam ampule; nefopam ampule 50 mg; Other Names: ACUPAN
Active Comparator: diphenhydramine; administration of intravenous diphenhydramine to prevent Rituximab Transfusion Reaction	Drug: diphenhydramine ampule; diphenhydramine ampule 10 mg; Other Names: Allermine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
transfusion reaction	fever, riger, rash, chills, pruritus and bronchospasm	30 min

Collaborators and Investigators

• Sponsor: Ministry Of Health / Nineveh Health Directorate
• Investigators: Study Chair: moataz alani, Ministry Of Health / Nineveh Health Directorate

Study record dates

Study Major Dates

• Study Start (Anticipated): December 20, 2022
• Primary Completion (Anticipated): October 20, 2023
• Study Completion (Anticipated): November 20, 2023

Study Registration Dates

• First Submitted: December 4, 2022
• First Submitted That Met QC Criteria: December 4, 2022
• First Posted (Actual): December 13, 2022

Study Record Updates

• Last Update Posted (Estimate): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hematologic Diseases; Transfusion Reaction; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Hypnotics and Sedatives; Anesthetics, Local; Anti-Allergic Agents; Sleep Aids, Pharmaceutical; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Diphenhydramine; Promethazine; Nefopam
• Other Study ID Numbers: nefopam with rituximab

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No