Pain Evaluation During Follicle Aspiration: Comparison of Two Sedation Protocols
November 13, 2023 updated by: University Hospital, Ghent
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 Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Ghent, Belgium, 9000
- Ghent University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 43 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Healthy women and female infertility patients
- Between 18 and 43 years of age
Exclusion Criteria:
- Patients with a known allergy to alfentanil hydrochloride or comparable drugs (morphine, cocaine)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Administration of low dose of alfentanil hydrochloride before paracervical block
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Administration of low dose alfentanil hydrochloride before paracervical block
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|
Active Comparator: 2
Administration of alfentanil hydrochloride dose after paracervical block
|
Normal dose of alfentanil hydrochloride is administered after paracervical block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pain relief
Time Frame: During and immediately after surgery
|
During and immediately after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Frank Dumortier, MD, University Hospital, Ghent
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2008
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
August 27, 2008
First Submitted That Met QC Criteria
August 27, 2008
First Posted (Estimated)
August 28, 2008
Study Record Updates
Last Update Posted (Actual)
November 15, 2023
Last Update Submitted That Met QC Criteria
November 13, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008/291
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.