Recruiting

Nitrous Oxide

Sponsor:

Strata Medical Innovations

Code:

NCT02119403

Conditions

Anesthesia

Eligibility Criteria

Sex: All

Age: 3+

Healthy Volunteers: Not accepted

Interventions

There are no other inteventions.

Study Details

Brief summary:

To study the safety and efficacy of Hand Held Nitrous. A device that delivers 120 seconds of up to 72% nitrous oxide and ambient air.

Conditions

Anesthesia

Study ID

NCT02119403

Start date

Jul, 2013

Status verified date

Apr, 2014

Completion date

Dec, 2014

Anticipated

Primary completion date

Dec, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Any patient undergoing a painful office procedure or exam

Exclusion Criteria:

  • Women that are Pregnant
  • Children under three years of age

Study Design

Enrollment

250 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Hand Held NitrousTM

There are no other interventions to this device

Interventions

There are no other inteventions.

This device gives patients the opportunity to receive nitrous oxide where no such opportunity exists. There is no other intervention available that creates immediate short term minimal sedation.

Primary outcome measure

  • This study measures the types of complications (if any) associated with the use of small set amount of nitrous oxide. [ Time Frame: The patient is under observation for the length of the procedure or until baseline parameters are met (under 10 minutes). No followup is required. ]

Central Contacts and Locations

Central contacts

Mark W Aldana, B.S. MBA

806-787-0756

Locations

Lubbock Urology

Recruiting

Lubbock, Texas, United States, 79423

Principal Investigator:

Howard Beck

Other Medical Practices

Recruiting

Lubbock, Texas, United States, 79423

Contacts

Mark Aldana

806-787-0756

More Information

Sponsor

Strata Medical Innovations

Last update posted

Apr 21, 2014

Last verified

Apr, 2014

Keywords

  • Minimal Sedation nitrous oxide

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Strata Medical Innovations on 2014-04-21.