Pain Evaluation During Follicle Aspiration: Comparison of Two Sedation Protocols

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00742807
First received: August 27, 2008
Last updated: February 1, 2013
Last verified: February 2013
  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 4

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:


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: May 2013
Estimated Primary Completion Date: May 2013 (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
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, see Learn About Clinical Studies.

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:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00742807     History of Changes
Other Study ID Numbers: 2008/291
Study First Received: August 27, 2008
Last Updated: February 1, 2013
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
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014