Cervical BiopsyNCT03532841
Role of Oral Tramadol 50 mg in Reducing Pain During Colposcopy-directed Cervical Biopsy
A study testing an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tablet in people with Cervical Biopsy, run by Cairo University.
Trial summary
The study objective is to evaluate the effectiveness of oral tramadol 50 mg in reducing pain during the colposcopy-directed cervical biopsy.half of the patients will receive oral tramadol tablets and the other half will receive a placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Biopsy
- What is being tested?
- an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2018to 30 Aug 2018
- Phase
- Interventional
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women with abnormal cervical cytology candidate for colposcopy and colposcopically directed biopsy or loop electrosurgical excision procedure.
Who cannot join
- Patients taking psychotropic or anticoagulant medications or with histories of bleeding disorders or bleeding ulcers.
- Cervical and vaginal infection
- pregnant patients.
- Patients who had taken analgesics in the previous 24 hours, had a history of drug abuse or allergy to tramadol or opioids
- Patients with contraindications to tramadol as severe asthma, severe renal or hepatic impairment, People with uncontrolled epilepsy.
- People under the influence of (intoxicated with) alcohol, sleeping tablets, tranquilisers, psychotropic drugs (those affecting mood or emotions) or other opioid painkillers, e.g. morphine, codeine.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Oral Tramadol 50 mg in Reducing Pain During Colposcopy-directed Cervical Biopsy: A Randomised Double-blind Placebo-controlled Trial
The study objective is to evaluate the effectiveness of oral tramadol 50 mg in reducing pain during the colposcopy-directed cervical biopsy.half of the patients will receive oral tramadol tablets and the other half will receive a placebo.
Read the detailed description
.Colposcopy-directed cervical biopsy (CDB) is a procedure performed in women with abnormal Papanicolaou smear or abnormal human papillomavirus (HPV) testing whose cervical lesions are colposcopically identified. Generally, no anaesthesia is needed for the procedure which can be done on an outpatient basis.The degree of pain associated with this procedure varies from mild to severe and many studies suggested that pain levels are often high reaching a score of more than 40 points on a 100-point visual analogue scale (VAS). Tramadol hydrochloride is an orally active centrally acting synthetic opioid. It is an atypical analgesic with a dual mechanism of action: serotonin and norepinephrine reuptake inhibition and modest l-opioid agonist. It has a lower incidence of respiratory depression, cardiac depression, side effects on smooth muscle and abuse potential as compared to typical opioid agents
- Conditions
- Cervical Biopsy
- Being tested
- an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tablet, Placebo Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tabletDrug
Group I will receive an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tablet one hour before the procedure.
Placebo Oral TabletDrug
Also called placebo comparator or group II
placebo tablet of the same shape,color and taste will be given in the placebo arm
| Study group | Role | What they receive |
|---|---|---|
| Group I (tramadol group) | Experimental | Group I will receive an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tablet one hour before the procedure. Receives: Drug: an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tablet |
| Group II (placebo oral tablet group) | Placebo comparator | group II will receive a placebo one hour before the procedure.the Treatment and placebo will be identical in form and packaging, without any identifying label. Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient-described pain level
the mean patient-described pain level will be measured with the visual analogue scale (VAS). Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-10. A higher score indicates greater pain intensity. Subjects will be told that the far left point will represent "no pain "and the far right point will represent "the worst pain you can imagine." They will be asked to mark a vertical line on the visual analogue scale during the procedure to note levels of discomfort.
Measured: immediately after speculum placement (baseline pain score).
patient-described pain level
the visual analogue scale score from 0-10
Measured: after the first ectocervical biopsy(approximately 5 minutes after speculum insertion)
patient-described pain level
(postprocedure pain score) using the visual analogue scale score from 0-10.
Measured: the overall pain at 30 min after the procedure (postprocedure pain score)
Secondary outcomes (1)
duration of colposcopy procedure.
relationship between pain score and colposcopy duration in minutes.
Measured: from speculum insertion to colposcopy removal at the end of procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start15 May 2018 (estimated)
- Primary completion20 Aug 2018 (estimated)
- Study completion30 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical BiopsyStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomised double-blind placebo-controlled trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Samy aly ashour, Cairo University
- Investigators
- AHMED SAMY, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532841
- Sponsor's protocol ID
- tramadol and colposcopy
- Status last verified
- May 2018
- First submitted
- 13 Apr 2018
- Last updated
- 22 May 2018
- 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 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Oral Tramadol 50 mg in Reducing Pain During Colposcopy-directed Cervical Biopsy: A Randomised Double-blind Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03532841
- Acronym / sponsor ID
- tramadol and colposcopy
- Conditions
- Cervical Biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 May 2018 (estimated)
- Primary completion
- 20 Aug 2018 (estimated)
- Study completion
- 30 Aug 2018 (estimated)
- First posted
- 22 May 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.
The study objective is to evaluate the effectiveness of oral tramadol 50 mg in reducing pain during the colposcopy-directed cervical biopsy.half of the patients will receive oral tramadol tablets and the other half will receive a placebo.
Detailed description
.Colposcopy-directed cervical biopsy (CDB) is a procedure performed in women with abnormal Papanicolaou smear or abnormal human papillomavirus (HPV) testing whose cervical lesions are colposcopically identified. Generally, no anaesthesia is needed for the procedure which can be done on an outpatient basis.The degree of pain associated with this procedure varies from mild to severe and many studies suggested that pain levels are often high reaching a score of more than 40 points on a 100-point visual analogue scale (VAS). Tramadol hydrochloride is an orally active centrally acting synthetic opioid. It is an atypical analgesic with a dual mechanism of action: serotonin and norepinephrine reuptake inhibition and modest l-opioid agonist. It has a lower incidence of respiratory depression, cardiac depression, side effects on smooth muscle and abuse potential as compared to typical opioid agents
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomised double-blind placebo-controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Group I (tramadol group) | Experimental | Drug: an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tabletGroup I will receive an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tablet one hour before the procedure. |
| Group II (placebo oral tablet group) | Placebo comparator | Drug: Placebo Oral Tabletgroup II will receive a placebo one hour before the procedure.the Treatment and placebo will be identical in form and packaging, without any identifying label. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women with abnormal cervical cytology candidate for colposcopy and colposcopically directed biopsy or loop electrosurgical excision procedure.
Key exclusion criteria (6 listed)
- Patients taking psychotropic or anticoagulant medications or with histories of bleeding disorders or bleeding ulcers.
- Cervical and vaginal infection
- pregnant patients.
- Patients who had taken analgesics in the previous 24 hours, had a history of drug abuse or allergy to tramadol or opioids
- Patients with contraindications to tramadol as severe asthma, severe renal or hepatic impairment, People with uncontrolled epilepsy.
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 |
|---|---|---|
| an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tabletGroup I will receive an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tablet one hour before the procedure. | Drug | Group I (tramadol group) |
| Placebo Oral TabletAlso: placebo comparator or group IIplacebo tablet of the same shape,color and taste will be given in the placebo arm | Drug | Group II (placebo oral tablet group) |
Primary outcome
patient-described pain level
Time frame: immediately after speculum placement (baseline pain score).
the mean patient-described pain level will be measured with the visual analogue scale (VAS). Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-10. A higher score indicates greater pain intensity. Subjects will be told that the far left point will represent "no pain "and the far right point will represent "the worst pain you can imagine." They will be asked to mark a vertical line on the visual analogue scale during the procedure to note levels of discomfort.
patient-described pain level
Time frame: after the first ectocervical biopsy(approximately 5 minutes after speculum insertion)
the visual analogue scale score from 0-10
patient-described pain level
Time frame: the overall pain at 30 min after the procedure (postprocedure pain score)
(postprocedure pain score) using the visual analogue scale score from 0-10.
1 secondary outcome
duration of colposcopy procedure.
Time frame: from speculum insertion to colposcopy removal at the end of procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Cervical Biopsy
RecruitingObservational study
The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Endometrial and Cervical Cancer. A Multicenter Study.
Endometrial Cancer, Cervical Cancer
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 principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tablet in people with Cervical Biopsy, run by Cairo University.
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 1 inclusion and 6 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 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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 SAMY, MD (00201100681167, ahmedsamy8233@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient-described pain level (time frame: immediately after speculum placement (baseline pain score).). 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 22 May 2018; AzTrials last refreshed its copy on 8 Nov 2026.