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PainPhase 2/3VRSNCT02203175

Prevention of Propofol Injection Pain

A Phase 2/3 study testing saline, fentanyl and propofol in people with Pain, run by Yeditepe University Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Pain
What is being tested?
saline, fentanyl and propofol
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
1 siteTurkey (Türkiye)
Study dates
Apr 2011to Apr 2012
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-65 age
  • ASA status I-II
  • Scheduled for elective surgery

Who cannot join

  • Communication difficulty
  • Psychiatric and neurolojic disorders
  • History of allergy to the study drugs
  • Use of analgesics or sedative drugs within 24 hours before surgery.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Yeditepe University Hospital

    Istanbul, Devlet Yolu, Ankara Cad 102/104, Kozyatagi, 34752

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Fentanyl-propofol Mixture on Propofol Injection Pain.

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.

Read more

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.

Read the detailed description

150 ASA I-II patients, aged 18-65 year and scheduled for elective surgery were enrolled in the study. Patients were randomly assigned to one of three equal groups using an Excel (Microsoft , USA) generated randomization table. No patient received premedication. On arrival at the operation room after monitoring [ECG, noninvasive blood pressure, pulse oximeter and bispectral index (BIS)], a 20 gauge cannula was inserted into a vein on the dorsum of the patient's nondominant hand and %0.9 NaCl infusion was started at a rate of 5 ml/kg/h for 5 min, then i.v. infusion was stopped and the arm with the i.v. line was elevated for 15 s for drainage of venous blood. A tourniquet was placed on the forearm to produce a venous occlusion for 1 minute. The patients were pretreated by the anesthesiologist blinded to the groups. Before the anesthesia induction, Group C (Control, n=50) and group M (mixture, n=50) received 5 ml isotonic saline whereas group F (fentanyl, n=50)received 2micgr/kg fentanyl diluted with saline at a total volume of 5 ml as a pretreatment. (Propofol 1% Fresenius-FRESENIUS CABI- Fentanyl 0,05 mg/ml JANSSEN-CILAG ) The drugs were prepared by one of the investigators blinded to the study groups. Pretreatment solutions were identical in appearance. pH value of the fentanyl, propofol and fentanyl-propofol mixture was measured at the laboratory of our university with pH meter. For the patients in Group M a mixture of propofol and fentanyl was prepared using 20 ml propofol and 4 ml fentanyl. After the tourniquet was released, patients in Group C and F received 5 ml propofol whereas patients in Group M received 5 ml of this mixture. 10 seconds after the study drugs had been given, a standart question about the comfort of the injection was asked to the patient. We used the verbal rating scale (VRS) for evaluation of propofol injection pain. (0: none (negative response to questioning), 1: mild pain (pain reported only in response to questioning without any behavioral signs, 2: moderate pain (pain reported in response to questioning and accompanied by a behavioral sign or pain reported spontaneously without questioning), 3: severe pain (strong vocal response or response accompanied by facial grimacing, arm withdrawal or tears). All patients were able to answer the question about the pain and in all patients BIS was above 80 at that moment. The remaining dose of propofol and fentanyl was then given to complete the induction of anesthesia. Complete induction dose was propofol 2 mg/kg and fentanyl 2 mcg/kg. Because Group F and Group M had already received 2 mcg/kg fentanyl before, only Group C patients received 2mcg/kg fentanyl after the muscle relaxant. Before the induction of anesthesia, anesthesiologist explained all the patients that they will receive an iv. anesthetic that might lead to pain on the injection point, hand or arm.

STATISTICAL ANALYSES: Propofol injection pain was the primary outcome in the study. It is reported that the incidence of propofol injection pain is approximately 70 % and to decrease this incidence to 35% , it is calculated that 49 patients were needed in each group with a type I error of 0.05 and power of 90% . Due to possible drop outs in all groups 50 patients were taken into the study. Demographic data were compared with Student's t test . Fisher's Exact test and x2 tests were used to assess differences between categorical variables. A p value < 0.05 was considered significant.

Conditions
Pain
Being tested
saline, fentanyl, propofol
Keywords
propofol, pretreatment, mixture
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • salineDrug

    Also called serum phisyologic

    Before the anesthesia induction, 5 ml isotonic saline

  • fentanylDrug

    Also called talinat

    before the anesthesia induction 50 mcgr fentanyl

  • propofolDrug

    Also called pofol, diprivan

    during anesthesia 50 mg proposal with 50 mcgr fentanyl

Study groups in NCT02203175
Study groupRoleWhat they receive
Group C (plasebo): no pretreatmentPlacebo comparatorsaline injection
Receives: Drug: saline; Drug: fentanyl; Drug: propofol
propofol and fentanylActive comparatorpropofol 50 mg with fentanyl 50 mcgr iv during anesthesia induction ones time
Receives: Drug: fentanyl; Drug: propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. complete response

    The primary outcome is complete response: A complete response is defined as no pain during proposal injection.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2014 (estimated)
  2. Study startApr 2011
  3. Primary completionApr 2012
  4. Study completionApr 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02203175
Sponsor's protocol ID
100-26.01.2011
Acronym
VRS
Status last verified
Sep 2014
First submitted
30 Jun 2014
Last updated
25 Sep 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing saline, fentanyl and propofol in people with Pain, run by Yeditepe University Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

complete response (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2014.

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