Comparison of the analgesic effect of nebulized Ketamine versus intravenous Ketorolac in reducing pain of patients with renal colic who refer to emergency department

Comparison of analgesic effect of nebulized  Ketamine vs IV Ketorolac in reducing pain of patients with renal colic.

Phase 3, randomized, triple-blind, controlled clinical trial with parallel group design of 108 patients.

Therapeutic trial in the emergency department of Imam Hossein hospital in Shahroud as a triple-blind(patient, responsible for outcome assessment and statistical analyzer). Assign the code to each of the treatment groups that the nurse is aware of. Patients with renal colic with inclusion criteria are randomly admitted to the intervention or control group. For the intervention group, nebulization 0.5 mg per kg of Ketamine + injection of 1 cc of normal saline and for the control group injection of 1 mg/kg of Ketorolac + nebulization 0.5 cc/kg of distilled water is prescribed. If the pain is not controlled after 2 hours, 0.1 mg/kg of Morphine is injected. The patient's pain is measured according to the NRS and side effects before the study, 5, 15, 30 and 60 minutes after the study. Measuring patient satisfaction at the end of the study.

Inclusion: between 20 to 70 years old, Pain in one side flank. Exclusion: Unstable (SBP<90, HR>100 or HR<60, fever), pregnant, has one kidney, acute abdominal signs (tenderness, guarding, rebound tenderness), hasn't informed consent, history of addiction, history of take analgesic during the previous 6 hours.

Intervention group: The nurse nebulizes 0.5mg/kg Ketamine and injects 1cc normal saline for each patient. Control group: The nurse injects 1mg/kg of Ketorolac and 0.5cc/kg of distilled water is nebulizes for each patient.

Score of renal colic pain in numeric rating scale

Patient will be randomly divided into 2 groups of 54, using random allocation software. Treatments will start randomly from the first patient who has inclusion criteria. First, the numbers 1 to 108 will be written on 108 envelopes. There is a sheet containing the code of each patient's treatment  in each envelope, which is defined by the random allocation software that determines the treatment of each patient. Every patient with inclusion criteria will be allocated an envelope.

This study is double-blinded. To blind the patient, the  pain assessor and statistical analyzer a code will be allocated for each patient. Just emergency medicine specialist and nurse know the meaning of the cods. To make the patient blind, Ketorolac syringe and a placebo nebulizer or Ketamine nebulizer and a placebo syringe will be prepared. After collecting the data, the data will be entered into SPSS using random allocation software codes and will be provided to the statistical analyzer for analysis. Pain is a mental variable, therefore, making the pain assessor blind is important. So, the pain assessor who assesses the intensity of pain doesn't know the codes of each treatment, just knows the treatment code of each patient.