Role of Nefopam in Rituximab Transfusion Reaction
Primary Purpose
Nefopam
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Nefopam ampule
diphenhydramine ampule
Sponsored by
About this trial
This is an interventional treatment trial for Nefopam
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
nefopam
diphenhydramine
Arm Description
administration of intravenous nefopam to prevent Rituximab Transfusion Reaction
administration of intravenous diphenhydramine to prevent Rituximab Transfusion Reaction
Outcomes
Primary Outcome Measures
transfusion reaction
fever, riger, rash, chills, pruritus and bronchospasm
Secondary Outcome Measures
Full Information
NCT ID
NCT05648058
First Posted
December 4, 2022
Last Updated
December 13, 2022
Sponsor
Ministry Of Health / Nineveh Health Directorate
1. Study Identification
Unique Protocol Identification Number
NCT05648058
Brief Title
Role of Nefopam in Rituximab Transfusion Reaction
Official Title
Role of Nefopam in Rituximab Transfusion Reaction
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 20, 2022 (Anticipated)
Primary Completion Date
October 20, 2023 (Anticipated)
Study Completion Date
November 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ministry Of Health / Nineveh Health Directorate
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nefopam
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nefopam
Arm Type
Experimental
Arm Description
administration of intravenous nefopam to prevent Rituximab Transfusion Reaction
Arm Title
diphenhydramine
Arm Type
Active Comparator
Arm Description
administration of intravenous diphenhydramine to prevent Rituximab Transfusion Reaction
Intervention Type
Drug
Intervention Name(s)
Nefopam ampule
Other Intervention Name(s)
ACUPAN
Intervention Description
nefopam ampule 50 mg
Intervention Type
Drug
Intervention Name(s)
diphenhydramine ampule
Other Intervention Name(s)
Allermine
Intervention Description
diphenhydramine ampule 10 mg
Primary Outcome Measure Information:
Title
transfusion reaction
Description
fever, riger, rash, chills, pruritus and bronchospasm
Time Frame
30 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
fakhraldin marwan
Phone
07817639470
Email
drfakhralin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
zainab thanon
Phone
07518097301
Email
zainabthanon@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
moataz alani
Organizational Affiliation
Ministry Of Health / Nineveh Health Directorate
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
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Role of Nefopam in Rituximab Transfusion Reaction
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