Pain Evaluation During Follicle Aspiration: Comparison of Two Sedation Protocols - Full Text View

Sponsored by:	University Hospital, Ghent
Information provided by:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00742807

Purpose

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'

Condition	Intervention	Phase
Pain	Drug: Low dose of alfentanil hydrochloride Drug: Normal dose of alfentanil hydrochloride	Phase IV

Drug Information available for: Alfentanil Alfentanil hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Pain Evaluation During Follicle Aspiration: Comparison of Two Sedation Protocols

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:

Pain relief [ Time Frame: During and immediately after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	August 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Administration of low dose of alfentanil hydrochloride before paracervical block	Drug: Low dose of alfentanil hydrochloride Administration of low dose alfentanil hydrochloride before paracervical block
2: Active Comparator Administration of alfentanil hydrochloride dose after paracervical block	Drug: Normal dose of alfentanil hydrochloride Normal dose of alfentanil hydrochloride is administered after paracervical block

Eligibility

Ages Eligible for Study:	18 Years to 43 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742807

Contacts

Contact: Frank Dumortier, MD

Frank.dumortier@ugent.be

Locations

Belgium
Ghent University Hospital	Recruiting
Ghent, Belgium, 9000
Principal Investigator: Frank Dumortier, MD

Sponsors and Collaborators

University Hospital, Ghent

Investigators

Principal Investigator:

Frank Dumortier, MD

Ghent University Hospital

More Information

Website of the Ghent University Hospital This link exits the ClinicalTrials.gov site

Responsible Party:	Ghent University Hospital ( Frank Dumortier )
Study ID Numbers:	2008/291
Study First Received:	August 27, 2008
Last Updated:	September 5, 2008
ClinicalTrials.gov Identifier:	NCT00742807
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Hospital, Ghent:

sensation
relief
during
surgery

Study placed in the following topic categories:

Alfentanil
Pain

Additional relevant MeSH terms:

Anesthetics, Intravenous
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Narcotics
Pharmacologic Actions
Sensory System Agents

Anesthetics, General
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009