COLONOSCOPY
Conditions
Interventions
Trade Name: ENTONOX
Product Name: ENTONOX GAS
Pharmaceutical Form: Inhalation gas
Pharmaceutical form of the placebo: Injection*
Route o
Sponsors
HULL AND EAST YORKSHIRE NHS TRUST
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients undergoing colonoscopy will be invited to join the trial. The inclusion criteria are: a. All patients undergoing elective colonoscopy b. Male and female patients Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The exclusion criteria are: a. History of chronic pulmonary disease. b. History of past colonic resection c. History of abdominal pain/ perianal pain/positive scores on the visual analogue scores preprocedure. d. History of intolerance to any drugs e. Refusal to enter the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint used to measure the outcome in this study would be adequate pain relief as measured on the validated visual analogue scale ; Main Objective: The aims of this study are: a. To investigate the possible benefits of using inhaled entonox for sedation and analgesia during colonoscopy. b. To compare the analgesia thus achieved with the conventional intravenous sedation using midazolam/fentanyl. ; Secondary Objective: c. To ascertain if conscious sedation with entonox is associated with significantly lesser complications than the intravenous sedation? d. To investigate if there is a faster recovery of psychomotor function with entonox as compared with the currently used methods of sedation facilitating early discharge from the endoscopic suite? | — |
Countries
United Kingdom
Outcome results
None listed