Injection PainPhase 4NCT02285972
Efficacy of Intravenous Dexketoprofen and Tenoxicam on Propofol Associated Injection Pain
A Phase 4 study testing saline, dexketoprofen and tenoxicam in people with Injection Pain, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
Propofol remains the most common drug for induction of general anaesthesia, although it causes considerable pain or discomfort on injection. Anesthesia providers have attempted a large number of remedies to prevent this pain on injection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Injection Pain
- What is being tested?
- saline, dexketoprofen and tenoxicam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2014to Apr 2015
- Phase
- Phase 4
- 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
- American Society of Anesthesiologists (ASA) physical status 1 and 2
- 18 - 65 years
- general anesthesia scheduled for elective surgery
Who cannot join
- age < 18 years, > 65 years
- pregnancy
- patients requiring a rapid sequence induction
- refusal to participate and patients already participating in another study
- allergy to study drugs
- communication difficulty
Show all 11Show fewer
- psychiatric and neurolojic disorders
- use of analgesics or sedative drugs within 24 hours before surgery.
- emergency surgery
- history of drug or alcohol abuse
- ASA 3 and above
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital
Altinordu, Ordu, 52100
About this study
Propofol remains the most common drug for induction of general anaesthesia, although it causes considerable pain or discomfort on injection. Anesthesia providers have attempted a large number of remedies to prevent this pain on injection. Previously explored ideas include injecting propofol into larger veins, warming of the hand with hot packs, and intravenous pretreatment with numerous other medications. No studies to date have looked at the dexketoprofen and tenoxicam for the pretreatment of pain on injection caused by propofol. The investigators propose studying the use of dexketoprofen and tenoxicam for pretreatment of propofol related pain on injection.
- Conditions
- Injection Pain
- Being tested
- saline, dexketoprofen, tenoxicam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salineDrug
Also called serum physiologic
before the anesthesia induction, 2mL saline iv injection
dexketoprofenDrug
Also called Arveles, Leodex
before the anesthesia induction, 50 mg (2mL) iv dexketoprofen
tenoxicamDrug
Also called Oksamen-L, Tilcotil
before the anesthesia induction, 20 mg (2mL) iv tenoxicam
| Study group | Role | What they receive |
|---|---|---|
| saline | Placebo comparator | Not described Receives: Drug: saline |
| dexketoprofen | Active comparator | Not described Receives: Drug: dexketoprofen |
| tenoxicam | Active comparator | Not described Receives: Drug: tenoxicam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal Pain Score
Measured: Approximately one minute following administration of propofol.
Facial Pain Score
Measured: Approximately one minute following administration of propofol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injection PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, özgür yağan, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285972
- Sponsor's protocol ID
- Odu-5
- Status last verified
- Nov 2014
- First submitted
- 1 Nov 2014
- Last updated
- 21 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intravenous Dexketoprofen and Tenoxicam on Propofol Associated Injection Pain
- ClinicalTrials.gov ID
- NCT02285972
- Acronym / sponsor ID
- Odu-5
- Conditions
- Injection Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 7 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Propofol remains the most common drug for induction of general anaesthesia, although it causes considerable pain or discomfort on injection. Anesthesia providers have attempted a large number of remedies to prevent this pain on injection. Previously explored ideas include injecting propofol into larger veins, warming of the hand with hot packs, and intravenous pretreatment with numerous other medications. No studies to date have looked at the dexketoprofen and tenoxicam for the pretreatment of pain on injection caused by propofol. The investigators propose studying the use of dexketoprofen and tenoxicam for pretreatment of propofol related pain on injection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| saline | Placebo comparator | Drug: saline |
| dexketoprofen | Active comparator | Drug: dexketoprofen |
| tenoxicam | Active comparator | Drug: tenoxicam |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical status 1 and 2
- 18 - 65 years
- general anesthesia scheduled for elective surgery
Key exclusion criteria (11 listed)
- age < 18 years, > 65 years
- pregnancy
- patients requiring a rapid sequence induction
- refusal to participate and patients already participating in another study
- allergy to study drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| salineAlso: serum physiologicbefore the anesthesia induction, 2mL saline iv injection | Drug | saline |
| dexketoprofenAlso: Arveles, Leodexbefore the anesthesia induction, 50 mg (2mL) iv dexketoprofen | Drug | dexketoprofen |
| tenoxicamAlso: Oksamen-L, Tilcotilbefore the anesthesia induction, 20 mg (2mL) iv tenoxicam | Drug | tenoxicam |
Primary outcome
Verbal Pain Score
Time frame: Approximately one minute following administration of propofol.
Facial Pain Score
Time frame: Approximately one minute following administration of propofol.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing saline, dexketoprofen and tenoxicam in people with Injection Pain, run by Ordu University 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 11 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 21 Apr 2015. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Verbal Pain Score (time frame: Approximately one minute following administration of propofol.). The study lists 2 primary outcomes in all. 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 21 Apr 2015.