High Concentration Continuous Flow Nitrous Oxide Use for Procedural-induced Pain or Anxiety During Pediatric Minor Procedures
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- FLACC Pain Scale
Study Overview
Brief Summary
Title:
High-concentration continuous flow nitrous oxide use for procedural-induced pain or anxiety during pediatric minor procedures.
Objective: To assess whether the use of high-concentration continuous flow nitrous oxide in addition to standard management increases the comfort level in pediatric patients undergoing minor procedures compared to standard management alone.
Detailed Description
Title:
High-concentration continuous flow nitrous oxide use for procedural-induced pain or anxiety during pediatric minor procedures
Brief Summary:
Background: Over the past 10 years pediatric emergency departments (PED) throughout the country have adopted the concept of an "ouchless" PED, using both pharmacologic and non-pharmacologic methods to achieve this goal. There are a number of minor procedures performed routinely in a PED. Despite our interest in an "ouchless" PED, many of these procedures are performed without full attention to patient comfort. Some procedures, such as laceration repair, require local anesthesia, while others, such as intravenous catheter placement, are usually performed without local anesthesia. All of these minor procedures, however, are ones in which the risk of parenteral procedural sedation outweighs the benefit.
Due to the awareness of trying to create as pain-free an experience as possible, the use of high-concentration nitrous oxide (>50%) in the pediatric outpatient setting has grown and is used in PEDs throughout the country. Nitrous oxide is a colorless, non-narcotic, analgesic gas. Its efficacy and safety have been well documented in anesthesia, pediatric and dental literature. Over the last 30 years, nitrous oxide has been incorporated in the outpatient pediatric setting for procedural analgesia. At Jacobi Medical Center (JMC), nitrous oxide has been successfully used for children undergoing a variety of minor procedures in the PED.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Minor Procedure
- •Age 3 - 12 years
Exclusion Criteria
- •Behavioral Disorders
- •Anxiety Score <10
Arms & Interventions
Nitrous Oxide
Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.
Intervention: Nitrous Oxide (Drug)
Outcomes
Primary Outcomes
FLACC Pain Scale
Time Frame: peak pain during procedure approximately 2-5 minutes into the procedure
The primary outcome will be the FLACC (Face, Legs, Activity, Cry, Consolability) Pain scale measured intra-procedure. The scale measures facial expression, movement of legs, general activity, presence and quality of cry and the need and ability to be consoled. Scoring for each category ranges from 0 (no response to pain) to 2 (maximum response to pain). The scores are totaled and a total score ranging from 0-10 is reported.
Secondary Outcomes
- M-YPAS Anxiety Scale(measured pre-procedure at time provider explains procedure to the patient, and during procedure at peak pain time approximately 2-5 minutes into the procedure)