Development of a New Method for Analgesia

NCT ID: NCT00791024

Last Updated: 2015-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-01-31

Brief Summary

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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

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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).

Conditions

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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single arm

Group Type EXPERIMENTAL

CRC-Pharma 001

Intervention Type DRUG

50 mg

lidocaine suspension

Intervention Type DRUG

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

Interventions

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CRC-Pharma 001

50 mg

Intervention Type DRUG

lidocaine suspension

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients admitted for adipositas surgery
* Patients who attend for oesophagogastroduodenoscopy.

Exclusion Criteria

* Severe psychiatric diseases
* Alcohol abuse
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

Ove Andersen

OTHER

Sponsor Role lead

Responsible Party

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Ove Andersen

Research director

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Copenhagen University, Hvidovre Hospital

Hvidovre, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 22955296 (View on PubMed)

Other Identifiers

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CRC06

Identifier Type: -

Identifier Source: org_study_id

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