ClinicalTrials.gov
ClinicalTrials.gov Menu

Pain Evaluation During Follicle Aspiration: Comparison of Two Sedation Protocols

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00742807
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : August 28, 2008
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
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'

Condition or disease Intervention/treatment Phase
Pain Drug: Low dose of alfentanil hydrochloride Drug: Normal dose of alfentanil hydrochloride Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pain Evaluation During Follicle Aspiration: Comparison of Two Sedation Protocols
Study Start Date : August 2008
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Pain relief [ Time Frame: During and immediately after surgery ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 University Hospital, Ghent

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00742807     History of Changes
Other Study ID Numbers: 2008/291
First Posted: August 28, 2008    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

Keywords provided by University Hospital, Ghent:
sensation
relief
during
surgery

Additional relevant MeSH terms:
Alfentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics