Intravenous Tramadol Versus Intravenous Paracetamol in Patients With Dysmenorrhea
Primary Purpose
Dysmenorrhea
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
tramadol
paracetamol
Sponsored by
About this trial
This is an interventional treatment trial for Dysmenorrhea
Eligibility Criteria
Inclusion Criteria:
- Patients with moderate to severe primary dysmenorrhea and visual analog scale (VAS) pain scores ≥40
- Patients over 18 years old
Exclusion Criteria:
- denied to give inform consent, irregular menstrual cycles, known or suspected secondary dysmenorrhea
- Renal or liver failure
- Allergy to the study drugs
- Receiving pain killer within the last 6 hours.
- Physical examination findings consistent with peritoneal irritation
- Pregnancy or patients with lactation
- Drug or Alcohol Abuse
Sites / Locations
- Aljazeerah Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
tramadol
paracetamol
Arm Description
Intravenous 100 mg tramadol in 100 ml saline with slow infusion over 10 minutes.
Intravenous 1 gm paracetamol in 100 ml saline with slow infusion over 10 minutes.
Outcomes
Primary Outcome Measures
acute pain of dysmenorrhea measured by visual analogue scale
Change in visual analogue scale at 15th minutes from baseline
pain of dysmenorrhea measured by visual analogue scale
Change in visual analogue scale at 30th minutes from baseline
pain of dysmenorrhea measured by visual analogue scale
Change in visual analogue scale at 60th minutes from baseline
Secondary Outcome Measures
Rescue drug need
the need for additional analgesic drug
adverse effects.
nausea, Vomiting, epigastric pain
Full Information
NCT ID
NCT03509740
First Posted
April 17, 2018
Last Updated
June 14, 2020
Sponsor
Cairo University
Collaborators
Algazeerah hospital
1. Study Identification
Unique Protocol Identification Number
NCT03509740
Brief Title
Intravenous Tramadol Versus Intravenous Paracetamol in Patients With Dysmenorrhea
Official Title
Efficacy and Safety of Intravenous Tramadol Versus Intravenous Paracetamol for Relief of Acute Pain of Primary Dysmenorrhea: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
April 25, 2018 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
October 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Algazeerah hospital
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
Patients presented with primary dysmenorrhea composed the study population. One gram paracetamol and 100 mg tramadol in 100 ml saline with a slow infusion were compared in ceasing dysmenorrhea in the emergency department
Detailed Description
Patients over 18 years old who presented with dysmenorrhea composed the study population. Patients received painkiller within the last six hours, physical findings consistent with peritoneal irritation, allergy to the study drugs, renal or liver failure, drug addiction, pregnancy or woman with lactation and denied to give inform consent were the exclusion criteria. The pain of the study patients is measured with the visual analogue scale at baseline, 15th and 30th minutes and 1 hour after study drug administration. At the end of the 60 minutes, rescue drug need is also recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tramadol
Arm Type
Experimental
Arm Description
Intravenous 100 mg tramadol in 100 ml saline with slow infusion over 10 minutes.
Arm Title
paracetamol
Arm Type
Active Comparator
Arm Description
Intravenous 1 gm paracetamol in 100 ml saline with slow infusion over 10 minutes.
Intervention Type
Drug
Intervention Name(s)
tramadol
Intervention Description
100 mg tramadol in 100 ml saline with slow infusion
Intervention Type
Drug
Intervention Name(s)
paracetamol
Other Intervention Name(s)
perfalgan
Intervention Description
Intravenous 1 gm paracetamol in 100 ml saline with slow infusion
Primary Outcome Measure Information:
Title
acute pain of dysmenorrhea measured by visual analogue scale
Description
Change in visual analogue scale at 15th minutes from baseline
Time Frame
15 minutes
Title
pain of dysmenorrhea measured by visual analogue scale
Description
Change in visual analogue scale at 30th minutes from baseline
Time Frame
30 minutes
Title
pain of dysmenorrhea measured by visual analogue scale
Description
Change in visual analogue scale at 60th minutes from baseline
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Rescue drug need
Description
the need for additional analgesic drug
Time Frame
30 minutes.
Title
adverse effects.
Description
nausea, Vomiting, epigastric pain
Time Frame
60 minutes
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with moderate to severe primary dysmenorrhea and visual analog scale (VAS) pain scores ≥40
Patients over 18 years old
Exclusion Criteria:
denied to give inform consent, irregular menstrual cycles, known or suspected secondary dysmenorrhea
Renal or liver failure
Allergy to the study drugs
Receiving pain killer within the last 6 hours.
Physical examination findings consistent with peritoneal irritation
Pregnancy or patients with lactation
Drug or Alcohol Abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AHMED SAMY, MD
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
mahmoud alalfy, MD
Organizational Affiliation
National Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmed Ali, mbbch
Organizational Affiliation
faculty of medicine al-azhar university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aljazeerah Hospital
City
Giza
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Intravenous Tramadol Versus Intravenous Paracetamol in Patients With Dysmenorrhea
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