Ketamine-Dexmedetomidine (Ketodex) versus Ketamine and ketofol for adult procedural sedation in Emergency Department

Determining the consistency and effictiveness of Ketadex for Procedural Sedation and Analgesia (PSA) in comparing to ketamine and ketofol Determining the hemodynamic impacts and side effects of ketamine, Ketadex and Ketofol injection in Procedural Sedation and Analgesia (PSA) Determining the analgesic effectivness of ketamine, Ketadex and Ketofol injection in Procedural Sedation and Analgesia (PSA) with Visual Analogue Scale (VAS) and Ramsay sedation score (RASS)

This is a three arm parallel group (double blinded) randomized clinical trial study (third phase) with 145 cases. Patients are simple randomized with table of random numbers in 3 groups.

In this study we compare the effectiveness and side effects of Ketodex with Ketamine and Ketofol in adults PSA who refer to Alzahra and Kashani hospitals in Isfahan city. Drugs are preparing with scientist and labeled. Patients, scientist, manager and statistical analyst are blinded to randomization and treatment protocol.

Inclusion Criteria: Patients with pain severity status of ASA I-III; Visual Analog Scale>4 Non-Inclusion Criteria: Addiction to drugs and analgesics; Use of analgesics in 24 hours ego; Underlying disease such as hypertension, liver and kidney disease); Pregnancy; Psychiatric disease such as psychosis; Severe verbal or hearing disability

Intervention group 1: injection of 1 mg/kg diluted Ketamine in 20 ml normal saline over 4 minutes Intervention group 2: injection of 0.5 mg/kg diluted Ketofol in 20 ml normal saline over 4 minutes Intervention group 3: injection of 1 mg/kg diluted Ketamine and 0.7 microgram/kg Dexmedetomidine in 20 ml normal saline over 4 minutes

Pain severity score with Visual Analog Scale; Hemodynamic changes; Arterial O2 saturation changes; Respiratory complications; Agitation

Simple randomization with table of random numbers. In this study, based on predefined 3-digit number (001,002,003,...) randomization table, blindly choose one number, then upper and below numbers choose vertically as treatment code for each patient. ٍAfter ending the the numbers, manager blindly choose another number again and apply the upper and below numbers for each patient. Every 3-digit number from 001 to 105, marked as one randomized treatment protocol (45 number for treatment protocol "A", 45 number for treatment protocol "B" and 45 number for treatment protocol "C"); study manager doesn't knowing about drug that use in each protocol. Chosen numbers must be lesser than sample size and greater numbers will be deleted. This protocol continued until all patients who meet inclusion criteria get a random number. Due to this method, patients stay on one treatment group, without knowing about treatment protocol.

Drugs are preparing with scientist and labeled (scientist is blinded to patient's treatment group and efficacy or complications of each groups). Patients are selected with randomized numeric table and don't aware about treatment protocol. Manager use treatment pathway base on patient randomization; blinded about drug that be used and record result and complications. Statistical analyst, analyses the study without knowing about patients group and give the results to researcher for conclusion.

Whole of data after coding

Accessibility after 2023

Everyone

For seemingly studies data released to academic chairman's

Isfahan University of Medical Sciences

Emailing to m_esmailian@med.mui.ac.ir