The Comparison of Post-Operative Recovery Agitation after Three Analgesic Methods: Ketadex; Ketofol and Ketamine administration in the Emergency Departments in Iran

Ketamine-related agitation is one of the most common post-analgesic complications in both adult and children. In the emergency department, managing this problem is important and remains to be a remarkable challenge. This study will assess the effect of dexmedetomidine in combination of ketamine on incidence of EA comparing to ketofol and ketamine as one sedative drug.

three groups, parallel groups (ketodex, ketofol, ketamine), double-blinded, phase III, 31 patients in each group,

The data recruiting physician and the patient will not know what the drug the nurse has used for analgesia induction or the group of the patient.

Female/Male age over 3 years American Society of Anesthesiology physical status I to III (ASA I-III) VAS score of pain equal to or higher than 4 need for painful procedures in Emergency Department

Depending on their random group, patients will receive slowly intravenous Ketadex (0.7 μg.kg-1 dexmedetomidine and 1 mg/kg ketamine in one syringe) over 4 minutes or ketofol (0.5 mg/kg from each of ketamine and propofol) or 1 mg/kg ketamine alone, both intravenously over 2 minutes. Additional sedative rescue doses will be provided as 0.25 mg/kg ketamine every 2 minutes, in all patients if needed.

Patient’s agitation score and sedation consistency, assessed by RASS score (e.g. Richmond Agitation Sedation Scale); Heart Rate, oxygen saturation, systolic and diastolic blood pressure will be continuously monitored before sedation until full recovery time and recorded every 5 minutes for 2 hours.

Using Google™ Random Number Generator we will obtain 90 random numbers among 1, 2 and 3, print them out on a piece of paper, put them each into a closed envelope, and after each patient fulfills the inclusion criteria, the patient will be taken to the operation room of the emergency departments with an envelope.

The nurse will use an analgesia induction drug based on the number in the envelope, after prepping the patient. Then, the nurse will discard the envelope, the drug, and the syringe and will call the physician in for continuing the procedure. The physician and the patient will not know what the drug the nurse has used or the group of the patient.

Data on agitation score and hemodynamic indices of the patients who are consciously informed and consented about the study and are included in the study will be shared.

The data will be available from six months after the end of the patient recruitment and will be published as an article and will always be available.

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