Prevention of Propofol Injection Pain

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Pain on injection of propofol is a comman problem. The investigators planned to evaluate the effect of propofol-fentanyl mixture on propofol injection pain and compare it with fentanyl pretreatment and control groups.

Following ethics committee approval, 150 ASA I,II patients (18-65 yr) undergoing general anesthesia were enrolled to this study. Exclusion criteria were communication difficulty, psychiatric, neurologic disorders and history of allergy. Patients were randomly assigned to one of tree equal groups. Before the anesthesia induction, Group C (Control, n=50) and group M (mixture, n=50) received 5 ml isotonic saline, group F (fentanyl, n=50)received 2micgr/kg fentanyl. 10 seconds after the study drugs had been given, a standart question about the comfort of the injection was asked to the patient. The investigators used the verbal rating scale (VRS) for evaluation of propofol injection pain. Statistical analyses were performed with Student's t and Fisher's exact tests; p value <0,05 was considered significant.

Demographic data was similar among the groups (table I) In group M, the number of the patients having propofol injection pain was significantly lower compared to groups F and C (p<0,001 for both) None of the patients in groups F and M experienced severe pain whereas 24 patients (48%) had severe pain in group C (p<0.001 for both).

This study shown that fentanyl-propofol mixture is more effective compared to both fentanyl pretreatment and placebo in preventing propofol injection pain.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yeditepe University Hospital
• Treatments: Fentanyl; Propofol

Criteria

Inclusion Criteria:

• 18-65 age

• ASA status I-II

• Scheduled for elective surgery

Exclusion Criteria:

• Communication difficulty

• Psychiatric and neurolojic disorders

• History of allergy to the study drugs

• Use of analgesics or sedative drugs within 24 hours before surgery.