Pain Evaluation During Follicle Aspiration: Comparison of Two Sedation Protocols

This study is currently recruiting participants.

Verified August 2011 by University Hospital, Ghent

First Received on August 27, 2008. Last Updated on August 16, 2011 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Pain Evaluation During Follicle Aspiration: Comparison of Two Sedation Protocols

Resource links provided by NLM:

Drug Information available for: Alfentanil hydrochloride Alfentanil

U.S. FDA Resources

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:	August 2011
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 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
Active Comparator: 2 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

Additional Information:

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

No publications provided

Responsible Party:	Frank Dumortier, Ghent University Hospital
ClinicalTrials.gov Identifier:	NCT00742807 History of Changes
Other Study ID Numbers:	2008/291
Study First Received:	August 27, 2008
Last Updated:	August 16, 2011
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Hospital, Ghent:

sensation
relief
during
surgery

Additional relevant MeSH terms:

Alfentanil
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents

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

ClinicalTrials.gov processed this record on February 09, 2012