Pain Evaluation During Follicle Aspiration: Comparison of Two Sedation Protocols

Phase 4

Withdrawn

• Conditions: Pain
• Interventions: Drug: Low dose of alfentanil hydrochloride; Drug: Normal dose of alfentanil hydrochloride

• Registration Number: NCT00742807
• Lead Sponsor: University Hospital, Ghent

Brief 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'

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-27
• Study First Submitted QC: 2008-08-27
• Study First Posted: 2008-08-28
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Low dose of alfentanil hydrochloride	Administration of low dose of alfentanil hydrochloride before paracervical block
2	Normal dose of alfentanil hydrochloride	Administration of alfentanil hydrochloride dose after paracervical block

Primary Outcome Measures

Name	Time	Method
Pain relief	During and immediately after surgery

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium