Trial Outcomes & Findings for Nitrous Oxide Use in Minor Procedures (NCT NCT01911351)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

82 participants

Primary outcome timeframe

peak pain during procedure approximately 2-5 minutes into the procedure

Results posted on

2016-04-11

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Management Patients randomized to this arm will receive standard management alone for their minor procedure.	Nitrous Oxide Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure. Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure.
Overall Study STARTED	39	43
Overall Study COMPLETED	39	43
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nitrous Oxide Use in Minor Procedures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Management n=39 Participants Patients randomized to this arm will receive standard management alone for their minor procedure.	Nitrous Oxide n=43 Participants Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure. Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure.	Total n=82 Participants Total of all reporting groups
Age, Categorical <=18 years	39 Participants n=5 Participants	43 Participants n=7 Participants	82 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	5 years n=5 Participants	6 years n=7 Participants	5 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	17 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants	43 participants n=7 Participants	82 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Standard Management n=39 Participants Patients randomized to this arm will receive standard management alone for their minor procedure.	Nitrous Oxide n=43 Participants Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure. Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure.
FLACC Pain Scale	8 units on a scale Interval 5.0 to 10.0	2 units on a scale Interval 0.0 to 5.0

SECONDARY outcome

Timeframe: 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

Secondary outcome will be the Modified YALE Preoperative Anxiety Scale, measured pre-procedure, and intra-procedure. This is a validated scale measuring anxiety by assessment of Activity, Vocalization, Emotional Expressivity, State of Arousal and Use of Parents. All categories have a maximum score of 4 except for Vocalization with a maximum score of 6. The scores within each category are totaled and a total anxiety score is reported ranging from 5 (no anxiety) to 22 (highest level of anxiety).

Outcome measures

Outcome measures
Measure	Standard Management n=39 Participants Patients randomized to this arm will receive standard management alone for their minor procedure.	Nitrous Oxide n=43 Participants Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure. Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure.
M-YPAS Anxiety Scale Preprocedural YPAS score	14 units on a scale Interval 12.0 to 18.0	14 units on a scale Interval 12.0 to 18.5
M-YPAS Anxiety Scale intraprocedural YPAS score	20 units on a scale Interval 15.0 to 22.0	10 units on a scale Interval 5.0 to 15.0

OTHER_PRE_SPECIFIED outcome

Timeframe: measure time duration of each procedure, average 5-15 minutes

Another outcome measure is to compare the change in length of the procedure with or without nitrous oxide intervention.

Outcome measures

Outcome measures
Measure	Standard Management n=39 Participants Patients randomized to this arm will receive standard management alone for their minor procedure.	Nitrous Oxide n=43 Participants Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure. Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure.
Length of the Procedure	11 minutes Interval 5.0 to 20.0	11 minutes Interval 5.0 to 16.0

OTHER_PRE_SPECIFIED outcome

Timeframe: measured at the end of each procedure, approximately 10 minutes after the procedure is completed

Population: In the Standard Management arm, 38/39 parents completed the survey

A parental survey was collected post-procedure regarding the overall comfort of the child during the procedure. Other questions included whether the procedure was successfully completed, if the procedure went better than expected, was the parent pleased with the medications used and whether the child tolerated the procedure. Answers were Strongly Agree, Agree, Neutral, Disagree and Strongly Disagree. We chose the question that asked whether the child was comfortable during the procedure as it was most relevant. The categories "Strongly Agree" and "Agree" were combined in both groups.

Outcome measures

Outcome measures
Measure	Standard Management n=38 Participants Patients randomized to this arm will receive standard management alone for their minor procedure.	Nitrous Oxide n=43 Participants Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure. Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure.
Percentage of Parents Who Reported That Their Child Was Comfortable During the Procedure	71 percentage of participants	91 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: measured at the end of each procedure, approximately 10 minutes after the completion of the procedure

Survey collection of rating of success of the procedure by one provider. Answers were Strongly Agree, Agree, Neutral, Disagree and Strongly Disagree. The first two categories were combined.

Outcome measures

Outcome measures
Measure	Standard Management n=39 Participants Patients randomized to this arm will receive standard management alone for their minor procedure.	Nitrous Oxide n=43 Participants Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure. Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure.
Percentage of Providers Who Rated the Procedure as Being Successful	70 percentage of participants	91 percentage of participants

Adverse Events

Standard Management

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nitrous Oxide

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Standard Management n=39 participants at risk Patients randomized to this arm will receive standard management alone for their minor procedure.	Nitrous Oxide n=43 participants at risk Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure. Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure.
Injury, poisoning and procedural complications hallucinations	0.00% 0/39 Continuous real time observation	2.3% 1/43 Continuous real time observation
Injury, poisoning and procedural complications emesis	0.00% 0/39 Continuous real time observation	4.7% 2/43 Continuous real time observation

Additional Information

Dr. Sandra Cunningham

NYCHHC Jacobi Medical Center

Phone: 718 918 5250

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place