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Development of a New Method for Analgesia

Primary Purpose

Analgesia

Status

Completed

Phase

Phase 1

Locations

Denmark

Study Type

Interventional

Intervention

CRC-Pharma 001

lidocaine suspension

About this trial

This is an interventional supportive care trial for Analgesia focused on measuring Analgesia Tests, Analog Pain Scale, Pain Measurement

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients admitted for adipositas surgery
Patients who attend for oesophagogastroduodenoscopy.

Exclusion Criteria:

Severe psychiatric diseases
Alcohol abuse

Sites / Locations

Copenhagen University, Hvidovre Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single arm

Arm Description

Outcomes

Primary Outcome Measures

VAS score

Secondary Outcome Measures

Questionnaire( examiner and patient)

Full Information

NCT ID

NCT00791024

First Posted

November 12, 2008

Last Updated

August 25, 2015

Sponsor

Ove Andersen

Collaborators

University of Copenhagen

1. Study Identification

Unique Protocol Identification Number

NCT00791024

Brief Title

Development of a New Method for Analgesia

Official Title

Phase One Study and Two of a New Method for Local Analgesia

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Ove Andersen

Collaborators

University of Copenhagen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Aim: To examine a new method to perform local anesthesia in order to diminish the inconvenience by the procedure in patients before performing intubation or oesophagogastroduodenoscopy.

Detailed Description

A phase one and two study. part one is performed as a single arm unblinded uncontrolled study in 16 obese patients undergoing awake intubation (investigational pill). The second part is a phase two study randomized single blinded study in 100 patient attending a day case endoscopy unit for oesophagogastroduodenoscopy (investigational pill versus lidocaine suspension).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Analgesia

Keywords

Analgesia Tests, Analog Pain Scale, Pain Measurement

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

126 (Actual)

8. Arms, Groups, and Interventions

Arm Title

single arm

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

CRC-Pharma 001

Intervention Description

50 mg

Intervention Type

Drug

Intervention Name(s)

lidocaine suspension

Intervention Description

5.0 ml lidocaine suspension(20mg/ml) adm. 10 min. before oesophagogastroduodenoscopy.

Primary Outcome Measure Information:

Title

VAS score

Time Frame

at day O and 3

Secondary Outcome Measure Information:

Title

Questionnaire( examiner and patient)

Time Frame

performed at day 0 and 3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients admitted for adipositas surgery Patients who attend for oesophagogastroduodenoscopy. Exclusion Criteria: Severe psychiatric diseases Alcohol abuse

Facility Information:

Facility Name

Copenhagen University, Hvidovre Hospital

City

Hvidovre

ZIP/Postal Code

2650

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

22955296

Citation

Mogensen S, Pulis S, Kristensen BB, Ravn L, Treldal C, Rasmussen M, Mogensen T, Andersen O. A new method to facilitate oro-tracheal intubation of awake patients: a pilot study. Eur J Anaesthesiol. 2012 Nov;29(11):546-7. doi: 10.1097/EJA.0b013e328357e4e5. No abstract available.

Results Reference

derived

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Development of a New Method for Analgesia

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