PainPhase 4NCT03506763
Effect of Pre-medication in Pain Measures on Office Hysteroscopy
A Phase 4 study testing Diclofenac oral + scopolamina oral in people with Pain, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Will be perform a RCT to compare pain measure on office hysteroscopy after pre-medication with oral analgesic. Patients will be alocate to oral sodic diclofenac, scopolamin or placebo. We will compare visual analog score of pain after the procedure. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- Diclofenac oral + scopolamina oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 231 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2017to 30 Jun 2019
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- indication of intrauterine evaluation
- Abnormal uterine bleeding
- post-menopause uterine bleeding
- infertility
- recurrent miscarriage
Who cannot join
- stenosis of the external cervical orifice,
- pelvic inflammatory disease,
- suspected gestation or pregnancy,
- active bleeding at the time of examination
- contraindication to the use of the study medication, diclofenac sodium and scopolamine,
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035003
Carlos A Souza, MD, +5551981189937, souza.cab@gmail.com
About this study
Official title: Effect of Pre-medication in Pain Measures on Office Hysteroscopy - Randomized Clinical Trial
Will be perform a RCT to compare pain measure on office hysteroscopy after pre-medication with oral analgesic. Patients will be alocate to oral sodic diclofenac, scopolamin or placebo. We will compare visual analog score of pain after the procedure.
Patients: patients with indication of office hysteroscopy to evaluate uterine intracavitary abnormality.
Read more
Interventions Group 1 (control) The patients will receive about 2 h prior to the procedure 2 placebo tablets.
Group 2 (diclofenac + scopolamine) The patients will receive about 2 h prior to the procedure 1 tablet of diclofenac sodium 50 mg and 1 tablet of scopolamine 2 mg.
Group 3 (diclofenac only). Patients will receive approximately 2 h prior to the procedure 1 tablet of diclofenac sodium 50 mg and 1 tablet of placebo.
Read the detailed description
Pain during and 30 minutes after a hysteroscopy will be measured through the visual analog pain scale of 10 centimeters, considering 0 (no pain) and 10 (unbearable pain or the greatest pain ever experienced). Acceptance of the procedure and assessed through the Likert 5-point scale: 1) totally disagree; 2) disagree; 3) I do not agree or disagree; 4) I agree and 5) I totally agree.There will also be a need for analgesia after the procedure, the time spent in the observation room and the onset of vagal symptoms such as dizziness, malaise, nausea, vomiting or syncope
- Conditions
- Pain
- Being tested
- Placebo Oral + Placebo Oral, Diclofenac oral + Placebo Oral, Diclofenac oral + scopolamina oral
- Keywords
- office hysteroscopy, pain measure
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Oral + Placebo OralDrug
Also called Placebo
Placebo Oral + Placebo Oral
Diclofenac oral + Placebo OralDrug
Also called Diclofenac 50 mg oral tablet
Diclofenac oral + Placebo Oral
Diclofenac oral + scopolamina oralDrug
Also called Diclofenac 50 mg oral tablet, scopolamin 10 mg oral tablet
Diclofenac oral + scopolamina oral
| Study group | Role | What they receive |
|---|---|---|
| Placebo Oral + Placebo Oral | Placebo comparator | Placebo Oral + Placebo Oral Receives: Drug: Placebo Oral + Placebo Oral |
| Diclofenac oral + Placebo Oral | Active comparator | Diclofenac oral + Placebo Oral Receives: Drug: Diclofenac oral + Placebo Oral |
| Diclofenac oral + scopolamina oral | Active comparator | Diclofenac oral + scopolamina oral Receives: Drug: Diclofenac oral + scopolamina oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measure
Pain Visual analogue score
Measured: until 1 hour after exam
Secondary outcomes (1)
Likert scale
Likert scale
Measured: until 1 hour after exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start1 Aug 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- Sequential
- Model description
- RCT
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 231 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joao Sabino, MD, Principal investigator, HCPA- Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506763
- Sponsor's protocol ID
- 65409017.0.0000.5327
- Status last verified
- Apr 2018
- First submitted
- 13 Apr 2018
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- 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 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-medication in Pain Measures on Office Hysteroscopy - Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03506763
- Acronym / sponsor ID
- 65409017.0.0000.5327
- Conditions
- Pain
- Keywords
- office hysteroscopy, pain measure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 231 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 24 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.
Will be perform a RCT to compare pain measure on office hysteroscopy after pre-medication with oral analgesic. Patients will be alocate to oral sodic diclofenac, scopolamin or placebo. We will compare visual analog score of pain after the procedure.
Patients: patients with indication of office hysteroscopy to evaluate uterine intracavitary abnormality.
Interventions Group 1 (control) The patients will receive about 2 h prior to the procedure 2 placebo tablets.
Group 2 (diclofenac + scopolamine) The patients will receive about 2 h prior to the procedure 1 tablet of diclofenac sodium 50 mg and 1 tablet of scopolamine 2 mg.
Group 3 (diclofenac only). Patients will receive approximately 2 h prior to the procedure 1 tablet of diclofenac sodium 50 mg and 1 tablet of placebo.
Detailed description
Pain during and 30 minutes after a hysteroscopy will be measured through the visual analog pain scale of 10 centimeters, considering 0 (no pain) and 10 (unbearable pain or the greatest pain ever experienced). Acceptance of the procedure and assessed through the Likert 5-point scale: 1) totally disagree; 2) disagree; 3) I do not agree or disagree; 4) I agree and 5) I totally agree.There will also be a need for analgesia after the procedure, the time spent in the observation room and the onset of vagal symptoms such as dizziness, malaise, nausea, vomiting or syncope
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Placebo Oral + Placebo Oral | Placebo comparator | Drug: Placebo Oral + Placebo OralPlacebo Oral + Placebo Oral |
| Diclofenac oral + Placebo Oral | Active comparator | Drug: Diclofenac oral + Placebo OralDiclofenac oral + Placebo Oral |
| Diclofenac oral + scopolamina oral | Active comparator | Drug: Diclofenac oral + scopolamina oralDiclofenac oral + scopolamina oral |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- indication of intrauterine evaluation
- Abnormal uterine bleeding
- post-menopause uterine bleeding
- infertility
- recurrent miscarriage
Key exclusion criteria (5 listed)
- stenosis of the external cervical orifice,
- pelvic inflammatory disease,
- suspected gestation or pregnancy,
- active bleeding at the time of examination
- contraindication to the use of the study medication, diclofenac sodium and scopolamine,
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 |
|---|---|---|
| Placebo Oral + Placebo OralAlso: PlaceboPlacebo Oral + Placebo Oral | Drug | Placebo Oral + Placebo Oral |
| Diclofenac oral + Placebo OralAlso: Diclofenac 50 mg oral tabletDiclofenac oral + Placebo Oral | Drug | Diclofenac oral + Placebo Oral |
| Diclofenac oral + scopolamina oralAlso: Diclofenac 50 mg oral tablet, scopolamin 10 mg oral tabletDiclofenac oral + scopolamina oral | Drug | Diclofenac oral + scopolamina oral |
Primary outcome
Pain measure
Time frame: until 1 hour after exam
Pain Visual analogue score
1 secondary outcome
Likert scale
Time frame: until 1 hour after exam
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
- 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.
Joao Sabino, MD principal investigator
HCPA- Professor
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 Diclofenac oral + scopolamina oral in people with Pain, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 5 inclusion and 5 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 24 Apr 2018. 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 Brazil. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos A Souza, MD (+5551981189937, cbsouza@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain measure (time frame: until 1 hour after exam). 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 24 Apr 2018.