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NCT00742807 Clinical Trial

Pain Evaluation During Follicle Aspiration: Comparison of Two Sedation Protocols

Pain Clinical Trial

Official title:
Pain Evaluation During Follicle Aspiration: Comparison of Two Sedation Protocols

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00742807
Other study ID # 2008/291
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date August 2008
Est. completion date May 2015

Study information
Verified date November 2023
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 compared with each other and pain relief measured using the 'Visual Analogue Scale' and the 'Short-Form McGill Questionnaire'

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 43 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Low dose of alfentanil hydrochloride
Administration of low dose alfentanil hydrochloride before paracervical block
• Normal dose of alfentanil hydrochloride
Normal dose of alfentanil hydrochloride is administered after paracervical block

Locations
Country Name City State
Belgium Ghent University Hospital Ghent

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain relief During and immediately after surgery
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