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Prevention of Propofol Injection Pain

NCT02203175 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2014-09-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

saline

Before the anesthesia induction, 5 ml isotonic saline

DRUG

fentanyl

before the anesthesia induction 50 mcgr fentanyl

DRUG

propofol

during anesthesia 50 mg proposal with 50 mcgr fentanyl

Sponsors & Collaborators

  • Yeditepe University Hospital

    lead OTHER

Principal Investigators

  • ferdi menda, assoc. prof. · Yeditepe University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02203175 on ClinicalTrials.gov