Trial Outcomes & Findings for Isopropyl Alcohol vs Ondansetron for Nausea in the Emergency Department (NCT NCT02760069)
NCT ID: NCT02760069
Last Updated: 2020-07-23
Results Overview
Full Scale Name: Nausea 100-mm visual analogue scale. Scale Construct: Measures nausea as reported by the patient Scale Range: Minimum is 0 (no nausea) to 100 (worst nausea imaginable). These values quantify, on an interval scale anchored at 0, the patient's subjective sensation of nausea. Higher values represent worse outcomes (e.g., more nausea). Patient makes a single vertical mark on a 100 mm horizontal line with 0 at the left and 100 on the right to depict their nausea.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
122 participants
Primary outcome timeframe
30 minutes post intervention
Results posted on
2020-07-23
Participant Flow
Participant milestones
| Measure |
Inhaled ISO + Oral Ondansetron
Inhaled isopropyl alcohol pads as needed for nausea (up to q30 minutes) and drink oral elixir comprising ondansetron (4 mg).
Inhaled isopropyl alcohol: Patients will inhale from isopropyl alcohol pads as needed for nausea up to q30 minutes.
Oral ondansetron: Patients will drink elixir containing 4 mg ondansetron in 5 ml of solution. National Drug Code (NDC) 0054-0064-47.
|
Inhaled ISO + Oral Placebo
Inhaled isopropyl alcohol pads as needed for nausea (up to q30 minutes) and drink oral placebo elixir.
Inhaled isopropyl alcohol: Patients will inhale from isopropyl alcohol pads as needed for nausea up to q30 minutes.
Oral placebo: Subjects will drink solution comprised of 0.25 ml of Oral Sweet Sugar Free NDC 0574-0302-16 with 4.75 ml of sterile water for dilution NDC 0264-2101-00
|
Inhaled Placebo + Oral Ondansetron
Inhaled normal saline pads as needed for nausea (up to q30 minutes) and drink oral placebo elixir.
Oral ondansetron: Patients will drink elixir containing 4 mg ondansetron in 5 ml of solution. National Drug Code (NDC) 0054-0064-47.
Inhaled normal saline: Patients will inhale from normal saline pads as needed for nausea up to q30 minutes.
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
41
|
41
|
|
Overall Study
COMPLETED
|
40
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Inhaled ISO + Oral Ondansetron
Inhaled isopropyl alcohol pads as needed for nausea (up to q30 minutes) and drink oral elixir comprising ondansetron (4 mg).
Inhaled isopropyl alcohol: Patients will inhale from isopropyl alcohol pads as needed for nausea up to q30 minutes.
Oral ondansetron: Patients will drink elixir containing 4 mg ondansetron in 5 ml of solution. National Drug Code (NDC) 0054-0064-47.
|
Inhaled ISO + Oral Placebo
Inhaled isopropyl alcohol pads as needed for nausea (up to q30 minutes) and drink oral placebo elixir.
Inhaled isopropyl alcohol: Patients will inhale from isopropyl alcohol pads as needed for nausea up to q30 minutes.
Oral placebo: Subjects will drink solution comprised of 0.25 ml of Oral Sweet Sugar Free NDC 0574-0302-16 with 4.75 ml of sterile water for dilution NDC 0264-2101-00
|
Inhaled Placebo + Oral Ondansetron
Inhaled normal saline pads as needed for nausea (up to q30 minutes) and drink oral placebo elixir.
Oral ondansetron: Patients will drink elixir containing 4 mg ondansetron in 5 ml of solution. National Drug Code (NDC) 0054-0064-47.
Inhaled normal saline: Patients will inhale from normal saline pads as needed for nausea up to q30 minutes.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
Baseline Characteristics
Isopropyl Alcohol vs Ondansetron for Nausea in the Emergency Department
Baseline characteristics by cohort
| Measure |
Inhaled ISO + Oral Ondansetron
n=40 Participants
Inhaled isopropyl alcohol pads as needed for nausea (up to q30 minutes) and drink oral elixir comprising ondansetron (4 mg).
Inhaled isopropyl alcohol: Patients will inhale from isopropyl alcohol pads as needed for nausea up to q30 minutes.
Oral ondansetron: Patients will drink elixir containing 4 mg ondansetron in 5 ml of solution. National Drug Code (NDC) 0054-0064-47.
|
Inhaled ISO + Oral Placebo
n=40 Participants
Inhaled isopropyl alcohol pads as needed for nausea (up to q30 minutes) and drink oral placebo elixir.
Inhaled isopropyl alcohol: Patients will inhale from isopropyl alcohol pads as needed for nausea up to q30 minutes.
Oral placebo: Subjects will drink solution comprised of 0.25 ml of Oral Sweet Sugar Free NDC 0574-0302-16 with 4.75 ml of sterile water for dilution NDC 0264-2101-00
|
Inhaled Placebo + Oral Ondansetron
n=40 Participants
Inhaled normal saline pads as needed for nausea (up to q30 minutes) and drink oral placebo elixir.
Oral ondansetron: Patients will drink elixir containing 4 mg ondansetron in 5 ml of solution. National Drug Code (NDC) 0054-0064-47.
Inhaled normal saline: Patients will inhale from normal saline pads as needed for nausea up to q30 minutes.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
117 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
40 participants
n=5 Participants
|
120 participants
n=4 Participants
|
|
Nausea 100-mm visual analogue scale
|
53 units on a scale
STANDARD_DEVIATION 22 • n=5 Participants
|
51 units on a scale
STANDARD_DEVIATION 21 • n=7 Participants
|
51 units on a scale
STANDARD_DEVIATION 20 • n=5 Participants
|
52 units on a scale
STANDARD_DEVIATION 21 • n=4 Participants
|
PRIMARY outcome
Timeframe: 30 minutes post interventionFull Scale Name: Nausea 100-mm visual analogue scale. Scale Construct: Measures nausea as reported by the patient Scale Range: Minimum is 0 (no nausea) to 100 (worst nausea imaginable). These values quantify, on an interval scale anchored at 0, the patient's subjective sensation of nausea. Higher values represent worse outcomes (e.g., more nausea). Patient makes a single vertical mark on a 100 mm horizontal line with 0 at the left and 100 on the right to depict their nausea.
Outcome measures
| Measure |
Inhaled ISO + Oral Ondansetron
n=40 Participants
Inhaled isopropyl alcohol pads as needed for nausea (up to q30 minutes) and drink oral elixir comprising ondansetron (4 mg).
Inhaled isopropyl alcohol: Patients will inhale from isopropyl alcohol pads as needed for nausea up to q30 minutes.
Oral ondansetron: Patients will drink elixir containing 4 mg ondansetron in 5 ml of solution. National Drug Code (NDC) 0054-0064-47.
|
Inhaled ISO + Oral Placebo
n=40 Participants
Inhaled isopropyl alcohol pads as needed for nausea (up to q30 minutes) and drink oral placebo elixir.
Inhaled isopropyl alcohol: Patients will inhale from isopropyl alcohol pads as needed for nausea up to q30 minutes.
Oral placebo: Subjects will drink solution comprised of 0.25 ml of Oral Sweet Sugar Free NDC 0574-0302-16 with 4.75 ml of sterile water for dilution NDC 0264-2101-00
|
Inhaled Placebo + Oral Ondansetron
n=40 Participants
Inhaled normal saline pads as needed for nausea (up to q30 minutes) and drink oral placebo elixir.
Oral ondansetron: Patients will drink elixir containing 4 mg ondansetron in 5 ml of solution. National Drug Code (NDC) 0054-0064-47.
Inhaled normal saline: Patients will inhale from normal saline pads as needed for nausea up to q30 minutes.
|
|---|---|---|---|
|
Nausea 100 mm Visual Analogue Scale (VAS)
|
23 units on a scale
Standard Deviation 25
|
19 units on a scale
Standard Deviation 18
|
42 units on a scale
Standard Deviation 27
|
SECONDARY outcome
Timeframe: Study duration (up to 5 hours post intervention)Whether patient required rescue anti-emetics (binary variable). Measured using nurse drug administration record.
Outcome measures
| Measure |
Inhaled ISO + Oral Ondansetron
n=40 Participants
Inhaled isopropyl alcohol pads as needed for nausea (up to q30 minutes) and drink oral elixir comprising ondansetron (4 mg).
Inhaled isopropyl alcohol: Patients will inhale from isopropyl alcohol pads as needed for nausea up to q30 minutes.
Oral ondansetron: Patients will drink elixir containing 4 mg ondansetron in 5 ml of solution. National Drug Code (NDC) 0054-0064-47.
|
Inhaled ISO + Oral Placebo
n=40 Participants
Inhaled isopropyl alcohol pads as needed for nausea (up to q30 minutes) and drink oral placebo elixir.
Inhaled isopropyl alcohol: Patients will inhale from isopropyl alcohol pads as needed for nausea up to q30 minutes.
Oral placebo: Subjects will drink solution comprised of 0.25 ml of Oral Sweet Sugar Free NDC 0574-0302-16 with 4.75 ml of sterile water for dilution NDC 0264-2101-00
|
Inhaled Placebo + Oral Ondansetron
n=40 Participants
Inhaled normal saline pads as needed for nausea (up to q30 minutes) and drink oral placebo elixir.
Oral ondansetron: Patients will drink elixir containing 4 mg ondansetron in 5 ml of solution. National Drug Code (NDC) 0054-0064-47.
Inhaled normal saline: Patients will inhale from normal saline pads as needed for nausea up to q30 minutes.
|
|---|---|---|---|
|
Number of Participants Who Required Rescue Anti-emetics
|
11 Participants
|
10 Participants
|
18 Participants
|
Adverse Events
Inhaled ISO + Oral Ondansetron
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Inhaled ISO + Oral Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Inhaled Placebo + Oral Ondansetron
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place