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Efficacy of 50% Nitrous Oxide/50% Oxygen Gas Premix in Chronic Leg Ulcer Debridement

NCT02696460 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2016-03-02

No results posted yet for this study

Summary

Adequate analgesia in serial chronic leg ulcer debridement can be difficult to achieve. A common analgesia method is the topical administration of local anesthetics directly onto the wound. However, complete wound debridement is often hampered by insufficient analgesia leading to interruption of the actual debridement and fragmentation of treatment into more frequent serial debridement sessions. Alternatively, the inhalation of an nitrous oxide/oxygen (N2O/O2) gas premix could be used for analgesia. In this study, the investigators have compared the analgesic method of an eutectic mixture of topically administered lidocaine/prilocaine cream (EMLA®) with the inhalation of an equimolar 50% N2O/50% O2 gas premix (Kalinox®) in serial leg ulcer debridement.

Conditions

  • Chronic Leg Ulcer

Interventions

PROCEDURE

N2O/O2 analgesia

Analgesia for ulcer debridement procedure is provided by the inhalation of N2O/O2 gas premix.

PROCEDURE

Lidocaine/Prilocaine analgesia

Analgesia for ulcer debridement procedure is provided by topically administered lidocaine/prilocaine cream.

Sponsors & Collaborators

  • Venenklinik Bellevue

    lead OTHER

Principal Investigators

  • Juerg Traber, MD · Venenklinik Bellevue

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-10-31
Completion
2011-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02696460 on ClinicalTrials.gov