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Nitrous Oxide for Analgesia During Colonoscopy

This study has been completed.
Sponsor:
Information provided by:
Rikshospitalet University Hospital
ClinicalTrials.gov Identifier:
NCT00318825
First received: April 25, 2006
Last updated: November 30, 2010
Last verified: April 2006
History of Changes
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Use of Nitrous Oxide for Analgesia During Colonoscopy - A Randomised Trial

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Rikshospitalet University Hospital

Additional 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
Study First Received: April 25, 2006
Last Updated: November 30, 2010
Health Authority: Norway: Institute for Medical Devices

Keywords provided by Rikshospitalet University Hospital:
Pain
Colonoscopy
Sedation

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

ClinicalTrials.gov processed this record on May 22, 2013