The Effect of Nebulized Ketamine in Treatment of Patients with Chronic Obstructive Pulmonary Disease Exacerbation (COPD exacerbation)

Evaluating the effect of nebulized Ketamine in treatment of patients with chronic obstructive pulmonary disease exacerbation

Two arm parallel group randomised clinical trial, double-blind, phase 3 on 80 patients (40 people in each group)

80 patients with COPD who referred to the emergency room of Shahid Rahmonun and Shahid Sadoughi hospitals, Yazd, Iran with moderate or severe exacerbation of symptoms and were divided into two intervention and placebo groups using a random number table. The evaluating doctor and the patient are blinded about the received medicine, and only the nurse knows that.

Exclusion criteria: under 16 and over 60 years old heart, kidney, liver failure Oral fever above 38.3° C Low or high blood pressure Decreased level of consciousness and other brain disorders Suspicion of other respiratory diseases Inability to use peak expiratory flow meter Severe respiratory distress requiring intubation or NIV Pregnant women Known allergy to ketamine

Control Group receives the main treatment with a standard dose (nebulizer 2.5 mg of albuterol and 5 mg of Atrovent and intravenous injection of methylprednisolone 1 mg per weight and oxygen with Venturi mask) along with nebulizer placebo (saline). Intervention Group: In addition to standard treatment, they receive ketamine nebulizer with a dose of 0.5 mg per weight and a maximum of 25 mg. After 20 minutes, if the symptoms do not improve, the above method is repeated again.

Age, gender, treatment group, PEFR, respiratory rate, heart rate, dyspnea severity score, Sa O2, VBG, need for intubation or NIV, need for hospitalization, level of satisfaction of the attending physician, rate of complications

From all patients with COPD who refer to the emergency department of Shahid Rahmonun and Shahid Sadouqi hospitals with moderate or severe exacerbation of symptoms, according to the entry and exit criteria, 80 people are included in the study and are divided into two intervention and placebo groups using a random number table. Tables of random numbers are prepared by computers that arrange numbers randomly, which are divided into blocks of five digits to facilitate its use. In this method, the community members are numbered from 1 to 80, then a row and a column of the table are randomly selected. The intersection point of the selected row and column is the starting point of sampling. (choose the point by closing eyes, placing finger or pen tip on the table). and only pays attention to and selects the smaller numbers. From this point, a plus or a cross is drawn. All the numbers that are added or crossed over are selected as members of the sample. This process continues until the required sample (40 cases) is selected.

The method of blinding was that a sheet with A and B written on it was placed in the envelopes. The evaluating doctor held these closed envelopes in front of the patient and asked them to choose one and without looking inside the envelope, he gave it to the relevant nurse, so that according to whether it was A or B inside the envelope, he would prescribe the medicine for the patient. The evaluating doctor did not know the type of medicine received by the patient. With this method, the patient did not know the type of treatment.

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