The effects of applying perianal local anesthetics on patient comfort during visual examination of the last part of large intestine

No effect of perianal application of topical anesthetics on patient comfort during non-sedated sigmoidoscopy: a randomized, placebo-controlled clinical trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000715976

Enrollment

175

Registered

2011-07-11

Start date

2008-11-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Patients were randomized to 3 groups according to perianal application of different topical agents 30 minutes before the procedure as follows: Group 1 - 5 mL of vaseline application (placebo) Group 2 - 5 mL of 2% lidocaine gel Group 3 - 5 ml of 2.5% lidocaine plus 2.5% prilocaine cream

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

ASA I-II patients undergoing sigmoidoscopy without sedation

Exclusion criteria

Exclusion criteria were use of anti-anxiety medicine within 48 hours before the procedure, cognitive dysfunction, past history of having lower endoscopy or anal/colorectal or gynecological surgery and complaint of pain at the anal area precluding examination.

Outcome results