Health TrialsbyHealthPanel

Inhaled Isopropyl Alcohol for Treatment of Nausea

ConditionsVomitingNauseaChildren, Only
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age7-17
SponsorState University of New York at Buffalo

About this trial

To determine the efficacy of inhaled isopropyl alcohol in treating nausea/vomiting among pediatric patients compared with the conventional ondansetron, or placebo treatment in a tertiary care pediatric emergency department.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients with a chief complaint of nausea or vomiting

Ages 7-178 years, both sexes

Weight ≥ 15 kg

Baxter Animated Retching Faces (BARF) nausea severity score ≥ 4/10

Disqualifiers

1. Require IV access

Inability to breathe in/out through the nose

Anosmia (self- or parental report)

Allergy to isopropyl alcohol or ondansetron

Trial design

Design model

Parallel

Treatments tested in this trial

  • Inhaled Isopropyl Alcohol

    Other intervention

    Isopropyl alcohol pad (Covidien Webcol 2 ply prep pads, saturated with 70% isopropyl alcohol) held 1-2 cm under the subject's nares

  • Oral Ondansetron

    Drug

    4 mg oral disintegrating ondansetron tablet once

  • Inhaled Placebo

    Other intervention

    Normal saline pad (Hygea sterile saline wipe) held 1-2 cm under the subject's nares

Treatment groups

84 Participants
are divided into 3 treatment groups
Group A: Inhaled Isopropyl AlcoholExperimental treatment 1 intervention
Group B: Oral OndansetronActive comparator 1 intervention
Group C: Inhaled PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Nausea Score at 30 Minutes

Baxter Animated Retching Faces nausea score, 0-10 with higher score meaning worse nausea

Time frame
30 minutes post-intervention as compared to baseline
2

Change in Nausea Score at 10 Minutes

Baxter Animated Retching Faces nausea score, 0-10 with higher score meaning worse nausea

Time frame
10 minutes post-interventnon as compared to baseline
3

Change in Nausea Score at Discharge

Baxter Animated Retching Faces nausea score, 0-10 with higher score meaning worse nausea

Time frame
At ED discharge (assessed up to 10 hours) as compared to baseline

Secondary outcomes

1

Vomiting

Number of episodes of vomiting post-intervention

Time frame
From intervention to time of ED discharge (assessed up to 10 hours)
2

Parent/Caregiver Satisfaction

Patient's parent/caregiver satisfaction score (very dissatisfied, dissatisfied, neutral, satisfied, very satisfied)

Time frame
At time of ED discharge (assessed up to 10 hours)
3

Nurse Satisfaction in Ease of Administering the Treatment

Patient's bedside nurse satisfaction score (very difficult, somewhat difficult, neutral, somewhat easy, very easy)

Time frame
At time of ED discharge (assessed up to 10 hours)
4

Length of Stay

Length of patient's stay in the emergency department

Time frame
From arrival to time of ED discharge (assessed up to 10 hours)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

State University of New York at Buffalo

Lead sponsor

Source ClinicalTrials.gov
Apply now