PainPhase 4NCT00742807
Pain Evaluation During Follicle Aspiration: Comparison of Two Sedation Protocols
A Phase 4 study testing Low dose of alfentanil hydrochloride and Normal dose of alfentanil hydrochloride in people with Pain, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Giving infiltration analgesia around the neck of the womb (= paracervical block, PCB) is frequently experienced as a painful procedure by women undergoing follicle aspiration. Two sedation protocols, where in the one protocol a low dose of alfentanil hydrochloride is already administered before the PCB, will be… Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- Low dose of alfentanil hydrochloride and Normal dose of alfentanil hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2008to May 2015
- 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 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy women and female infertility patients
- Between 18 and 43 years of age
Who cannot join
- Patients with a known allergy to alfentanil hydrochloride or comparable drugs (morphine, cocaine)
Trial locations and contacts
1 site in 1 country.
About this study
Giving infiltration analgesia around the neck of the womb (= paracervical block, PCB) is frequently experienced as a painful procedure by women undergoing follicle aspiration. Two sedation protocols, where in the one protocol a low dose of alfentanil hydrochloride is already administered before the PCB, will be compared with each other and pain relief measured using the 'Visual Analogue Scale' and the 'Short-Form McGill Questionnaire'
- Conditions
- Pain
- Being tested
- Low dose of alfentanil hydrochloride, Normal dose of alfentanil hydrochloride
- Keywords
- sensation, relief, during, surgery
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose of alfentanil hydrochlorideDrug
Administration of low dose alfentanil hydrochloride before paracervical block
Normal dose of alfentanil hydrochlorideDrug
Normal dose of alfentanil hydrochloride is administered after paracervical block
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Administration of low dose of alfentanil hydrochloride before paracervical block Receives: Drug: Low dose of alfentanil hydrochloride |
| 2 | Active comparator | Administration of alfentanil hydrochloride dose after paracervical block Receives: Drug: Normal dose of alfentanil hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
Measured: During and immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: No investigator to follow-up
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 University Hospital, GhentThe 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank Dumortier, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00742807
- Sponsor's protocol ID
- 2008/291
- Status last verified
- Nov 2023
- First submitted
- 27 Aug 2008
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Evaluation During Follicle Aspiration: Comparison of Two Sedation Protocols
- ClinicalTrials.gov ID
- NCT00742807
- Acronym / sponsor ID
- 2008/291
- Conditions
- Pain
- Keywords
- sensation, relief, during, surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No investigator to follow-up
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Aug 2008 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 28 Aug 2008 (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.
Giving infiltration analgesia around the neck of the womb (= paracervical block, PCB) is frequently experienced as a painful procedure by women undergoing follicle aspiration. Two sedation protocols, where in the one protocol a low dose of alfentanil hydrochloride is already administered before the PCB, will be compared with each other and pain relief measured using the 'Visual Analogue Scale' and the 'Short-Form McGill Questionnaire'
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Low dose of alfentanil hydrochlorideAdministration of low dose of alfentanil hydrochloride before paracervical block |
| 2 | Active comparator | Drug: Normal dose of alfentanil hydrochlorideAdministration of alfentanil hydrochloride dose after paracervical block |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy women and female infertility patients
- Between 18 and 43 years of age
Key exclusion criteria (1 listed)
- Patients with a known allergy to alfentanil hydrochloride or comparable drugs (morphine, cocaine)
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 |
|---|---|---|
| Low dose of alfentanil hydrochlorideAdministration of low dose alfentanil hydrochloride before paracervical block | Drug | 1 |
| Normal dose of alfentanil hydrochlorideNormal dose of alfentanil hydrochloride is administered after paracervical block | Drug | 2 |
Primary outcome
Pain relief
Time frame: During and immediately after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Website of the Ghent University HospitalLink provided by the sponsor.
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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.
Frank Dumortier, MD principal investigator
University Hospital, Ghent
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 Low dose of alfentanil hydrochloride and Normal dose of alfentanil hydrochloride in people with Pain, run by University Hospital, Ghent at 1 site in Belgium.
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 1 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: withdrawn, as of the sponsor's last update on 15 Nov 2023. 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 Belgium. 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 was withdrawn before enrolling participants, so there are no results.
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?
Pain relief (time frame: During and immediately after surgery). 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 15 Nov 2023.