Nitrous Oxide for Analgesia During Colonoscopy

This study is currently recruiting participants.

Verified by Rikshospitalet University Hospital, April 2006

First Received: April 25, 2006 Last Updated: May 25, 2006 History of Changes

Sponsored by:	Rikshospitalet University Hospital
Information provided by:	Rikshospitalet University Hospital
ClinicalTrials.gov Identifier:	NCT00318825

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Pharmacokinetics Study
Official Title:	Use of Nitrous Oxide for Analgesia During Colonoscopy – A Randomised Trial

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy

Drug Information available for: Nitrous oxide

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
Estimated Study Completion Date:	December 2006

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

Contacts

Contact: Michael Bretthauer, MD, PhD	4790132480	bretthauer@rikshospitalet.no
Contact: Lars Aabakken, MD, PhD	4723070000	aabakken@rikshospitalet.no

Locations

Norway
Rikshospitalet University Hospital	Recruiting
Oslo, Norway, 0027
Principal Investigator: Michael Bretthauer, MD, PhD

Sponsors and Collaborators

Rikshospitalet University Hospital

Investigators

Principal Investigator:

Michael Bretthauer, MD, PhD

Rikshospitalet HF

More Information

No publications provided

Study ID Numbers:	s-05225
Study First Received:	April 25, 2006
Last Updated:	May 25, 2006
ClinicalTrials.gov Identifier:	NCT00318825 History of Changes
Health Authority:	Norway: Institute for Medical Devices

Keywords provided by Rikshospitalet University Hospital:

Pain
Colonoscopy
Sedation

Study placed in the following topic categories:

Anesthetics, Inhalation
Anesthetics, General
Analgesics, Non-Narcotic
Nitrous Oxide
Central Nervous System Depressants

Anesthetics
Pain
Peripheral Nervous System Agents
Analgesics

Additional relevant MeSH terms:

Nitrous Oxide
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Pharmacologic Actions
Anesthetics, Inhalation
Analgesics, Non-Narcotic

Sensory System Agents
Anesthetics, General
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 30, 2009