Effect of isopropyl alcohol nasal inhalation and intravenous ondansetron versus placebo on nausea and vomiting in patients with head trauma: a randomized clinical trial

To assess the effect of isopropyl alcohol nasal inhalation and intravenous ondansetron versus placebo on nausea and vomiting in patients with head trauma

This is a randomized clinical trial, phase II, in which 228 eligible patients will be randomly assigned to the intervention and control groups

The eligible patients with head trauma who will refer to Besat Hospital in Hamadan City during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization.

Inclusion criteria: Age of 20 to 80 years Mild head trauma (GCS of 14 to 15) Exclusion criteria: Severe trauma to other parts of the body Hypersensitivity to isopropyl alcohol nasal inhalation and ondansetron Inhalation disorder Mental disorder

Intervention group 1: Inhalation of the saturated pad with 70% isopropyl alcohol for one minute at most 3 times in 2 minutes intervals Intervention group 2: Injection of intravenous ondansetron 0.1 mg/kg once Control group: Inhalation of the saturated pad with normal saline for one minute at most 3 times in 2 minutes intervals

Primary outcome: Assessing the severity of nausea and vomiting Secondary outcome: Assessing the severity of headache

The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare six sheets of paper, writing on two sheets the name of the intervention 1 and on two other sheets the name of the intervention 2 and on the third two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all six sheets are drawn. The six paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.