Effect of Dexmedetomidine on Pain Due to Propofol Injection

Not Applicable

• Conditions: Pain; Intravenous Propofol Injection
• Interventions: Drug: I.V injection of 10 ml normal saline; Drug: I.V injection of 0.50mic/kg of dexmedetomidine; Drug: I.V injection with 0.25mic/kg of dexmedetomidine

• Registration Number: NCT01463332
• Lead Sponsor: KVG Medical College and Hospital

Brief Summary

Propofol is commonly used IV anesthetic, it has been formulated in a concentration of 10 mg/ml in a fat emulsion consisting of 10% soybean oil (long-chain triglycerides). When used for anesthetic induction, propofol causes pain on injection in 28%-90% of patients. pain probably results from a direct irritant effect. Several methods have been used to reduce this pain. Lidocaine pretreatment has been commonly proposed to decrease propofol induced pain, but its failure rate is between 13-32%. Dexmedetomidine is highly selective alfa-2 adrenoreceptor agonist. Alpha-2 receptors are located on blood vessels where they inhibit norepinephrine release. Investigators, therefore, speculated that dexmedetomidine could attenuate the pain due to injection of propofol. Investigators conducted a study to determine the efficacy of dexmedetomidine in decreasing pain due to injection of propofol.

Detailed Description

Propofol solution is fat emulsion consisting of soyabean oil. When used for anesthetic induction, propofol causes pain or discomfort on injection. Many factors appear to affect the incidence of pain, which includes site of injection, size of vein, speed of injection, buffering effect of blood, temperature and composition of propofol solution and concomitant use of drugs such as local anaesthetics and opiates.

Pain on injection of propofol can be immediate or delayed. Immediate pain probably results from a direct irritant effect whereas delayed pain probably results from an indirect effect via the kinin cascade. Delayed pain has latency of between 10 and 20 s. The pain produced is usually described as tingling, cold, or numbing, at its worst, a severe burning pain proximal to the site of injection. This sensation tends to occur within 10-20 s of injection and lasts only for the duration of injection. Despite this discomfort, the incidence of phlebitis is less than 1%.

Several methods have been used to reduce this pain with limited success. Lidocaine pretreatment is commonly used to decrease propofol induced pain, but its failure rate is between 13-32%.

Dexmedetomidine is an selective alfa-2 adrenoreceptor agonist with supraspinal, spinal, and peripheral actions. Alpha-2 receptors are located on blood vessels where they inhibit norepinephrine release. Investigators, therefore, speculated that dexmedetomidine could attenuate the pain due to injection of propofol.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-09-30
• Status Verified: 2011-10
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Study First Submitted QC: 2011-10-31
• Last Update Submitted: 2011-10-31
• Study First Posted: 2011-11-01
• Last Update Posted: 2011-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• ASA I & II
• Both gender
• Age 18-60
• Elective surgery

Exclusion Criteria

• Patients taking sedatives or analgesics in the past 24 hours
• History of allergic reactions to anesthetic drugs,
• Atrio-ventricular conduction defects
• Cardiovascular disease and
• Pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group NS	I.V injection of 10 ml normal saline	Patients were randomly assigned in to three groups of 50 each using a computer-generated table of random numbers. Patients Group NS were injected intravenously with 10 ml of normal saline before injection of propofol.
Group D50	I.V injection of 0.50mic/kg of dexmedetomidine	Patients were randomly assigned in to three groups of 50 each using a computer-generated table of random numbers. Patients Group D50 were injected intravenously with 0.50mic/kg of dexmedetomidine diluted with normal saline into 10ml before injection of propofol.
Group D25	I.V injection with 0.25mic/kg of dexmedetomidine	Patients were randomly assigned in to three groups of 50 each using a computer-generated table of random numbers. Patients Group D25 were injected intravenously with 0.25mic/kg of dexmedetomidine diluted with normal saline into 10ml before injection of propofol.

Primary Outcome Measures

Name	Time	Method
Pain score after propofol injection	upto 24 hours	After injecting study drugs the pain score after propofol was assessed by using visual rating scale and given score according to severity of pain 0 = no pain,; 1. = mild pain or soreness,; 2. = moderate pain and; 3. = severe pain associated with facial grimacing, arm withdrawal, movement or both.

Secondary Outcome Measures

Name	Time	Method
Incidence of Pain recall in postoperative recovery room	Upto 24 hrs.	All patient were observed for 2-hrs in recovery room and were asked to recall if there was pain during injection of propofol in the recovery room and incidence of pain was graded as; 0-No recall of pain; 1-Recall of pain present.