Development of a New Method for Analgesia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Hvidovre University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Copenhagen
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00791024
First received: November 12, 2008
Last updated: May 11, 2009
Last verified: November 2008

November 12, 2008
May 11, 2009
November 2008
January 2010   (final data collection date for primary outcome measure)
VAS score [ Time Frame: at day O and 3 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00791024 on ClinicalTrials.gov Archive Site
Questionnaire( examiner and patient) [ Time Frame: performed at day 0 and 3 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Development of a New Method for Analgesia
Phase One Study and Two of a New Method for Local Analgesia

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.

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).

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Analgesia
  • Drug: CRC-Pharma 001
    50 mg
  • Drug: lidocaine suspension
    5.0 ml lidocaine suspension(20mg/ml) adm. 10 min. before oesophagogastroduodenoscopy.
Experimental: single arm
Interventions:
  • Drug: CRC-Pharma 001
  • Drug: lidocaine suspension
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
116
January 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Severe psychiatric diseases
  • Alcohol abuse
Both
18 Years to 70 Years
No
Contact: Ove Andersen, md, PhD 36323335 ext +45 ove.andersen@hvh.regionh.dk
Denmark
 
NCT00791024
CRC06
Yes
Ove Andersen Scientific Director, PhD, Clinical Research Centre Hvidovre University Hospital
Hvidovre University Hospital
University of Copenhagen
Not Provided
Hvidovre University Hospital
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP