Pain Evaluation During Follicle Aspiration: Comparison of Two Sedation Protocols

Ghent University Hospital (UZ)

Status and phase: Withdrawn; Phase 4

Conditions: Pain

Treatments: Drug: Normal dose of alfentanil hydrochloride; Drug: Low dose of alfentanil hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT00742807

2008/291

Details and patient eligibility

About

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'

Sex: Female

Ages: 18 to 43 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

1

Experimental group

Description:

Administration of low dose of alfentanil hydrochloride before paracervical block

Treatment:

Drug: Low dose of alfentanil hydrochloride

2

Active Comparator group

Description:

Administration of alfentanil hydrochloride dose after paracervical block

Treatment:

Drug: Normal dose of alfentanil hydrochloride