Role of Nefopam in Rituximab Transfusion Reaction
Sponsor
Ministry Of Health / Nineveh Health Directorate (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05648058
Collaborator
(none)
100
2
11
Study Details
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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Detailed Description
the two groups will be taken standard therapy (hydrocortisone vial 100 mg and acetaminophen 1000 mg) 30 min before rituximab
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Role of Nefopam in Rituximab Transfusion Reaction
Anticipated Study Start Date
:
Dec 20, 2022
Anticipated Primary Completion Date
:
Oct 20, 2023
Anticipated Study Completion Date
:
Nov 20, 2023
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: nefopam administration of intravenous nefopam to prevent Rituximab Transfusion Reaction |
Drug: Nefopam ampule
nefopam ampule 50 mg
Other Names:
|
Active Comparator: diphenhydramine administration of intravenous diphenhydramine to prevent Rituximab Transfusion Reaction |
Drug: diphenhydramine ampule
diphenhydramine ampule 10 mg
Other Names:
|
Outcome Measures
Primary Outcome Measures
- transfusion reaction [30 min]
fever, riger, rash, chills, pruritus and bronchospasm
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Ministry Of Health / Nineveh Health Directorate
Investigators
- Study Chair: moataz alani, Ministry Of Health / Nineveh Health Directorate
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ministry Of Health / Nineveh Health Directorate
ClinicalTrials.gov Identifier:
NCT05648058
Other Study ID Numbers:
- nefopam with rituximab
First Posted:
Dec 13, 2022
Last Update Posted:
Dec 15, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: