DysmenorrheaPhase 4NCT03509740
Intravenous Tramadol Versus Intravenous Paracetamol in Patients With Dysmenorrhea
A Phase 4 study testing tramadol and paracetamol in people with Dysmenorrhea, run by Cairo University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- tramadol and paracetamol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Apr 2018to 20 Oct 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with moderate to severe primary dysmenorrhea and visual analog scale (VAS) pain scores ≥40
- Patients over 18 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Intravenous Tramadol Versus Intravenous Paracetamol for Relief of Acute Pain of Primary Dysmenorrhea: A Randomized Controlled Trial
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
Read the 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.
- Conditions
- Dysmenorrhea
- Being tested
- tramadol, paracetamol
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tramadolDrug
100 mg tramadol in 100 ml saline with slow infusion
paracetamolDrug
Also called perfalgan
Intravenous 1 gm paracetamol in 100 ml saline with slow infusion
| Study group | Role | What they receive |
|---|---|---|
| tramadol | Experimental | Intravenous 100 mg tramadol in 100 ml saline with slow infusion over 10 minutes. Receives: Drug: tramadol |
| paracetamol | Active comparator | Intravenous 1 gm paracetamol in 100 ml saline with slow infusion over 10 minutes. Receives: Drug: paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute pain of dysmenorrhea measured by visual analogue scale
Change in visual analogue scale at 15th minutes from baseline
Measured: 15 minutes
pain of dysmenorrhea measured by visual analogue scale
Change in visual analogue scale at 30th minutes from baseline
Measured: 30 minutes
pain of dysmenorrhea measured by visual analogue scale
Change in visual analogue scale at 60th minutes from baseline
Measured: 60 minutes
Secondary outcomes (2)
Rescue drug need
the need for additional analgesic drug
Measured: 30 minutes.
adverse effects.
nausea, Vomiting, epigastric pain
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start25 Apr 2018
- Primary completion1 Oct 2018
- Study completion20 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Algazeerah hospital
- Responsible party
- Principal investigator, Ahmed Samy aly ashour, Cairo University
- Investigators
- AHMED SAMY, MD, Study director, Cairo Universitymahmoud alalfy, MD, Principal investigator, National Research CenterAhmed Ali, mbbch, Principal investigator, faculty of medicine al-azhar university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509740
- Sponsor's protocol ID
- dysmenorrhea
- Status last verified
- Jun 2020
- First submitted
- 17 Apr 2018
- Last updated
- 16 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Intravenous Tramadol Versus Intravenous Paracetamol for Relief of Acute Pain of Primary Dysmenorrhea: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03509740
- Acronym / sponsor ID
- dysmenorrhea
- Conditions
- Dysmenorrhea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Algazeerah hospital
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 20 Oct 2018 (actual)
- First posted
- 26 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tramadol | Experimental | Drug: tramadolIntravenous 100 mg tramadol in 100 ml saline with slow infusion over 10 minutes. |
| paracetamol | Active comparator | Drug: paracetamolIntravenous 1 gm paracetamol in 100 ml saline with slow infusion over 10 minutes. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with moderate to severe primary dysmenorrhea and visual analog scale (VAS) pain scores ≥40
- Patients over 18 years old
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tramadol100 mg tramadol in 100 ml saline with slow infusion | Drug | tramadol |
| paracetamolAlso: perfalganIntravenous 1 gm paracetamol in 100 ml saline with slow infusion | Drug | paracetamol |
Primary outcome
acute pain of dysmenorrhea measured by visual analogue scale
Time frame: 15 minutes
Change in visual analogue scale at 15th minutes from baseline
pain of dysmenorrhea measured by visual analogue scale
Time frame: 30 minutes
Change in visual analogue scale at 30th minutes from baseline
pain of dysmenorrhea measured by visual analogue scale
Time frame: 60 minutes
Change in visual analogue scale at 60th minutes from baseline
2 secondary outcomes
Rescue drug need
Time frame: 30 minutes.
adverse effects.
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AHMED SAMY, MD study director
Cairo University
mahmoud alalfy, MD principal investigator
National Research Center
Ahmed Ali, mbbch principal investigator
faculty of medicine al-azhar university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tramadol and paracetamol in people with Dysmenorrhea, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute pain of dysmenorrhea measured by visual analogue scale (time frame: 15 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.