NCT00318825

Brief Summary

The purpose of the study is to determine the analgetic effect of nitrous oxide during colonoscopy, compared to no sedation and intravenous (IV) sedation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4 pain

Timeline
Completed

Started Apr 2006

Typical duration for phase_4 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

December 1, 2010

Status Verified

April 1, 2006

Enrollment Period

2.4 years

First QC Date

April 25, 2006

Last Update Submit

November 30, 2010

Conditions

Pain

Keywords

PainColonoscopySedation

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

  • 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?

Interventions

Nitrous oxideDRUG

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients referred for colonoscopy

You may not qualify if:

  • Patients who don't understand information given
  • Age under 18 years
  • Pregnancy
  • Otitis/sinusitis
  • Ileus/bowel obstruction
  • Megacolon
  • Suspected pneumothorax

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rikshospitalet University Hospital

Oslo, 0027, Norway

Location

Related Publications (1)

  • Loberg M, Furholm S, Hoff I, Aabakken L, Hoff G, Bretthauer M. Nitrous oxide for analgesia in colonoscopy without sedation. Gastrointest Endosc. 2011 Dec;74(6):1347-53. doi: 10.1016/j.gie.2011.07.071.

    PMID: 22136779DERIVED

MeSH Terms

Conditions

Pain

Interventions

Nitrous Oxide

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrogen OxidesGasesInorganic ChemicalsNitrogen CompoundsOxidesOxygen Compounds

Study Officials

  • Michael Bretthauer, MD, PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 25, 2006

First Posted

April 27, 2006

Study Start

April 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

December 1, 2010

Record last verified: 2006-04

Locations

NO(1)