Pain Evaluation During Follicle Aspiration: Comparison of... | NCT00742807

Studies
Pain Evaluation During Follicle Aspiration: Comparison of Two Sedation Protocols

NCT00742807

Sponsor

University Hospital, Ghent

Status

Withdrawn

Last Update Posted

Nov 15, 2023Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Pain

Interventions

Low dose of alfentanil hydrochloride
Normal dose of alfentanil hydrochloride

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No investigator to follow-up

Expanded Access Info

Start Date

Aug 2008Actual

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Aug 27, 2008

First Submission Date that Met QC Criteria

Aug 27, 2008

First Posted Date

Aug 28, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2023

Last Update Posted Date

Nov 15, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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'

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Administration of low dose of alfentanil hydrochloride before paracervical block	Drug: Low dose of alfentanil hydrochloride
2	Active Comparator	Administration of alfentanil hydrochloride dose after paracervical block	Drug: Normal dose of alfentanil hydrochloride

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Low dose of alfentanil hydrochloride	Drug	Administration of low dose alfentanil hydrochloride before paracervical block	1

Measure	Description	Time Frame
Pain relief		During and immediately after surgery

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

43 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frank Dumortier, MD	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ghent University Hospital		Ghent		9000	Belgium

Label	URL
Website of the Ghent University Hospital	View source

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015760	Alfentanil

Ancestor Terms

ID	Term
D005283	Fentanyl
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided