Trial Outcomes & Findings for Inhalation Intervention for Nausea in the Emergency Department (NCT NCT02092441)

Results Overview

Primary outcome is nausea and vomiting measured on a scale from 0 ("no nausea") to 10 ("worst nausea imaginable") Verbal Numerical Response Scale (VNRS) at 10 minutes post intervention.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

80 participants

Primary outcome timeframe

10 minutes post intervention

Results posted on

2016-05-23

Participant Flow

Participant milestones

Participant milestones
Measure	Alcohol Prep Pad Group isopropyl alcohol prep pad Alcohol prep pad group: Subjects inhale scent of alcohol pad	Normal Saline Prep Pad normal saline prep pad Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads
Overall Study STARTED	37	43
Overall Study COMPLETED	37	43
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Inhalation Intervention for Nausea in the Emergency Department

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alcohol Prep Pad Group n=37 Participants isopropyl alcohol prep pad Alcohol prep pad group: Subjects inhale scent of alcohol pad	Normal Saline Prep Pad n=43 Participants normal saline prep pad Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads	Total n=80 Participants Total of all reporting groups
Age, Continuous	35.65116 years STANDARD_DEVIATION 14.17557 • n=5 Participants	31.94595 years STANDARD_DEVIATION 12.12652 • n=7 Participants	33.9375 years STANDARD_DEVIATION 13.3154 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	33 Participants n=7 Participants	56 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	10 Participants n=7 Participants	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: 10 minutes post intervention

Primary outcome is nausea and vomiting measured on a scale from 0 ("no nausea") to 10 ("worst nausea imaginable") Verbal Numerical Response Scale (VNRS) at 10 minutes post intervention.

Outcome measures

Outcome measures
Measure	Alcohol Prep Pad Group n=37 Participants isopropyl alcohol prep pad Alcohol prep pad group: Subjects inhale scent of alcohol pad	Normal Saline Prep Pad n=43 Participants normal saline prep pad Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads
Nausea Verbal Numerical Rating Scale (0-10) at 10 Minutes Post Intervention	3 VNRS Interval 2.0 to 5.0	6 VNRS Interval 4.5 to 8.0

SECONDARY outcome

Timeframe: 10 minutes post intervention

Scale ranges from 0 ("no pain") to 10 ("worst pain imaginable")

Outcome measures

Outcome measures
Measure	Alcohol Prep Pad Group n=37 Participants isopropyl alcohol prep pad Alcohol prep pad group: Subjects inhale scent of alcohol pad	Normal Saline Prep Pad n=43 Participants normal saline prep pad Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads
Verbal Numerical Rating Scale Pain Score (0-10) at 10 Minutes Post Intervention	6 VNRS Interval 4.0 to 7.0	6 VNRS Interval 2.0 to 7.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 minutes post intervention

Patient satisfaction of smelling prep pad to alleviate nausea on a scale from 1 ("completely unsatisfied") to 5 ("completely satisfied")

Outcome measures

Outcome measures
Measure	Alcohol Prep Pad Group n=37 Participants isopropyl alcohol prep pad Alcohol prep pad group: Subjects inhale scent of alcohol pad	Normal Saline Prep Pad n=43 Participants normal saline prep pad Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads
Satisfaction Measured on a 5-point Likert Scale	4 5 point Likert Scale Interval 3.0 to 5.0	2 5 point Likert Scale Interval 1.0 to 3.0

Adverse Events

Alcohol Prep Pad Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Saline Prep Pad

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael D. April

Brooke Army Medical Center

Phone: 210-916-6129

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place