Pain, ProcedurePhase 3OPHNCT02760888
Oral Tramadol Versus Diclofenac For Pain Relief Before Outpatient Hysteroscopy:
A Phase 3 study testing Tramadol and Diclofenac in people with Pain, Procedure, run by Ain Shams University at 1 site in Egypt.
Trial summary
The purpose of this study is there difference between the effect of Tramadol orally and Diclofenac orally with respect to : analgesic efficacy during diagnostic hysteroscopy in nulliparous women. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Pain, Procedure
- What is being tested?
- Tramadol and Diclofenac
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteEgypt
- Study dates
- May 2016to Jul 2016
- Phase
- Phase 3
- 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
- BMI raging between (18.5 - 30 ).
- Scheduled for diagnostic hysteroscopy only.
- All of them should have given informed written consent.
Who cannot join
- Any contraindication to hysteroscopy (e.g. suspected pregnancy, genital tract infection).
- Receiving any other form of analgesia.
- Patients with known cervical stenosis, polyps and ulcers.
- Previous cervical surgery.
- Patients who are planning to have invasive intrauterine therapeutic interventions during the hysteroscopy.
- known sensitivity to non-steroidal anti-inflammatory and opioids drugs.
- Known gastritis or peptic ulcer or cardiac disease or Respiratory dysfunction.
- Unwilling to comply with the protocol, and Participation in another clinical trial in the last three months prior to the start of this study
Trial locations and contacts
1 site in 1 country.
Ahmed Elsayed Elbohoty, MD contact
About this study
Official title: Oral Tramadol Versus Diclofenac For Pain Relief Before Outpatient Hysteroscopy: A Randomized Controlled Trial
The purpose of this study is there difference between the effect of Tramadol orally and Diclofenac orally with respect to : analgesic efficacy during diagnostic hysteroscopy in nulliparous women.
Read the detailed description
This prospective double-blind, randomized, clinical trial, will be conducted at Ain Shams University Maternity Hospital- Early Cancer Detection Unite [ECDU].
Patients fulfilling inclusion and exclusion criteria will be divided into three groups.
Group A (study group) Include 34 patients who will receive Tramadol 100mg orally 1 hour before the procedure.
Group B (study group) Include 34 patients who will receive Diclofenac 100mg orally 1 hour before the procedure.
Group C (control group) Include 34 patients who will receive a placebo.
Pain will evaluate on two separate occasion: immediately after the procedure and 15 minutes after procedure using a 100mm line visual analog scale.
- Conditions
- Pain, Procedure
- Being tested
- Tramadol, Diclofenac, Placebo
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TramadolDrug
Women will receive a oral Tramadol 100mg 1 hour before the procedure
DiclofenacDrug
Women will receive oral Diclofenac 100mg 1 hour before the procedure
PlaceboDrug
Women will receive a Placebo 1 hour before the procedure
| Study group | Role | What they receive |
|---|---|---|
| Tramadol | Active comparator | Women will receive oral tramadol 100 mg 1 hour before the procedure Receives: Drug: Tramadol |
| Diclofenac | Active comparator | Women will receive 100 mg diclofenac 1 hour before the procedure Receives: Drug: Diclofenac |
| Placebo | Placebo comparator | Women will receive a placebo 1 hour before the procedure Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during the procedure
Pain will be assessed using a visual analogue scale immediatly after inserting the hysterscopy
Measured: intraoperative
pain after the procedure
15 minutes after procedure using a 100mm line visual analog scale
Measured: 15 minutes after completing the procedure
Secondary outcomes (1)
Adverse effect and difficulties
Recorded in Case Record Form
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ProcedureStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Elsayed Hassan Elbohoty, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02760888
- Sponsor's protocol ID
- EDCU HY
- Acronym
- OPH
- Status last verified
- Dec 2015
- First submitted
- 30 Apr 2016
- Last updated
- 4 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Tramadol Versus Diclofenac For Pain Relief Before Outpatient Hysteroscopy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02760888
- Acronym / sponsor ID
- OPH / EDCU HY
- Conditions
- Pain, Procedure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 4 May 2016 (estimated)
- 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.
The purpose of this study is there difference between the effect of Tramadol orally and Diclofenac orally with respect to : analgesic efficacy during diagnostic hysteroscopy in nulliparous women.
Detailed description
This prospective double-blind, randomized, clinical trial, will be conducted at Ain Shams University Maternity Hospital- Early Cancer Detection Unite [ECDU].
Patients fulfilling inclusion and exclusion criteria will be divided into three groups.
Group A (study group) Include 34 patients who will receive Tramadol 100mg orally 1 hour before the procedure.
Group B (study group) Include 34 patients who will receive Diclofenac 100mg orally 1 hour before the procedure.
Group C (control group) Include 34 patients who will receive a placebo.
Pain will evaluate on two separate occasion: immediately after the procedure and 15 minutes after procedure using a 100mm line visual analog scale.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tramadol | Active comparator | Drug: TramadolWomen will receive oral tramadol 100 mg 1 hour before the procedure |
| Diclofenac | Active comparator | Drug: DiclofenacWomen will receive 100 mg diclofenac 1 hour before the procedure |
| Placebo | Placebo comparator | Drug: PlaceboWomen will receive a placebo 1 hour before the procedure |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI raging between (18.5 - 30 ).
- Scheduled for diagnostic hysteroscopy only.
- All of them should have given informed written consent.
Key exclusion criteria (8 listed)
- Any contraindication to hysteroscopy (e.g. suspected pregnancy, genital tract infection).
- Receiving any other form of analgesia.
- Patients with known cervical stenosis, polyps and ulcers.
- Previous cervical surgery.
- Patients who are planning to have invasive intrauterine therapeutic interventions during the hysteroscopy.
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 |
|---|---|---|
| TramadolWomen will receive a oral Tramadol 100mg 1 hour before the procedure | Drug | Tramadol |
| DiclofenacWomen will receive oral Diclofenac 100mg 1 hour before the procedure | Drug | Diclofenac |
| PlaceboWomen will receive a Placebo 1 hour before the procedure | Drug | Placebo |
Primary outcome
Pain during the procedure
Time frame: intraoperative
Pain will be assessed using a visual analogue scale immediatly after inserting the hysterscopy
pain after the procedure
Time frame: 15 minutes after completing the procedure
15 minutes after procedure using a 100mm line visual analog scale
1 secondary outcome
Adverse effect and difficulties
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2016.
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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 Elsayed Elbohoty, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tramadol and Diclofenac in people with Pain, Procedure, run by Ain Shams 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 4 May 2016. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Elsayed Elbohoty, MD (elbohoty79@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during the procedure (time frame: intraoperative). The study lists 2 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 4 May 2016.