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Nitrous Oxide for Analgesia During Colonoscopy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00318825
First Posted: April 27, 2006
Last Update Posted: December 1, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rikshospitalet University Hospital
  Purpose
The purpose of the study is to determine the analgetic effect of nitrous oxide during colonoscopy, compared to no sedation and intravenous (IV) sedation.

Condition Intervention Phase
Pain Drug: Nitrous oxide Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Use of Nitrous Oxide for Analgesia During Colonoscopy - A Randomised Trial

Resource links provided by NLM:


Further study details as provided by Rikshospitalet University Hospital:

Primary Outcome Measures:
  • Does the use of nitrous oxide (N2O) during colonoscopy result in adequate analgesia for the patient?

Secondary Outcome Measures:
  • Are there any side-effects due to the use of N2O during colonoscopy?
  • Is there a reduction in the number of patients needing IV sedation?
  • Is there any dose reduction of IV drugs?

Estimated Enrollment: 200
Study Start Date: April 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients referred for colonoscopy

Exclusion Criteria:

  • Patients who don't understand information given
  • Age under 18 years
  • Pregnancy
  • Otitis/sinusitis
  • Ileus/bowel obstruction
  • Megacolon
  • Suspected pneumothorax
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00318825


Locations
Norway
Rikshospitalet University Hospital
Oslo, Norway, 0027
Sponsors and Collaborators
Rikshospitalet University Hospital
Investigators
Principal Investigator: Michael Bretthauer, MD, PhD Oslo University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00318825     History of Changes
Other Study ID Numbers: s-05225
First Submitted: April 25, 2006
First Posted: April 27, 2006
Last Update Posted: December 1, 2010
Last Verified: April 2006

Keywords provided by Rikshospitalet University Hospital:
Pain
Colonoscopy
Sedation

Additional relevant MeSH terms:
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents