Injection Site IrritationNCT04582032
Effects of Cyclooxygenase (COX) 1-2 Inhibitors on Prevention of Rocuronium Injection Pain
A study testing Dexketoprofen (KETAVEL 50 mg/2 ml) and Saline (Isotonic Saline Solution 0.9% ) in people with Injection Site Irritation, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Purpose : The aim of the study is to investigate the effects of cox inhibitors as a rescue agent against the rocuronium pain Methodology : Sixty patients enrolled for the general anesthesia enrolled in this study. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Injection Site Irritation
- What is being tested?
- Dexketoprofen (KETAVEL 50 mg/2 ml) and Saline (Isotonic Saline Solution 0.9% )
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2020to 4 Jan 2021
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- non allergic to dexketoprofen
- 18-60 years old
- American Society of Anesthesiologists(ASA) 1-2-3
- 70-90 kg weigh
Who cannot join
- patients with psychiatric and mental problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kecioren Training and Research Hospital
Ankara
About this study
Official title: Effects of COX 1-2 Inhibitors on Prevention of Rocuronium Injection Pain: Controlled, Randomised, Double Blind Study
Purpose : The aim of the study is to investigate the effects of cox inhibitors as a rescue agent against the rocuronium pain Methodology : Sixty patients enrolled for the general anesthesia enrolled in this study. Patients were allocated into two groups (Group 1: Dexketoprofen group, Group 2: Control group) .Pain was evaluated by during rocuronium injection, patients were scored by a scale showed below.
0;No movement response to injection
Read more
- Mild movement response to injection
- Hand withdrawal response to injection
- Arm withdrawal response to injection Investigators also evaluated the pain with 2 questions when the patient was in the recovery room.
Question 1.What was the last feeling before participants fall into sleep? question 2. Did participants feel any pain on participants's hand during medication injection for anesthesia?
Read the detailed description
Purpose : Rocuronium bromide is a painful agent while general anesthesia induction. The aim of the study is to investigate the effects of cox inhibitors as a rescue agent against the rocuronium pain Methodology : Sixty patients enrolled for the general anesthesia enrolled in this study. Patients were allocated into two groups (Group 1: Dexketoprofen group, Group 2: Control group) .Pain was evaluated by during rocuronium injection, patients were scored by a scale showed below.
0;No movement response to injection
- Mild movement response to injection
- Hand withdrawal response to injection
- Arm withdrawal response to injection Investigators also evaluated the pain with 2 questions when the patient was in the recovery room.
Question 1.What was the last feeling before participants fall into sleep? question 2. Did participants feel any pain on participants's hand during medication injection for anesthesia?
- Conditions
- Injection Site Irritation
- Being tested
- Dexketoprofen (KETAVEL 50 mg/2 ml), Saline (Isotonic Saline Solution 0.9% )
- Keywords
- dexketoprofen, pain, rocuronium
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexketoprofen (KETAVEL 50 mg/2 ml)Drug
intravenous dexketoprofen (KETAVEL 50 mg/2 ml)
Saline (Isotonic Saline Solution 0.9% )Drug
intravenous 2 ml of saline
| Study group | Role | What they receive |
|---|---|---|
| Dexketoprofen group, | Active comparator | IV cannulation was performed on hand dorsum or brachial and canulation place was recorded. Patients allocated in dexketoprofen group were administered intravenous dexketoprofen (50 mg/2ml) and 0,3 mg/kg midazolam 10 minutes prior to general anesthesia induction Receives: Drug: Dexketoprofen (KETAVEL 50 mg/2 ml) |
| Saline group | Other | IV cannulation was performed on hand dorsum or brachial and canulation place was recorded. Patients allocated in control group were administered intravenous 2 ml of saline and 0,3 mg/kg midazolam 10 minutes prior to general anesthesia induction Receives: Drug: Saline (Isotonic Saline Solution 0.9% ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The injection pain due to rocuronium
Pain will be recorded and graded using a 4-point scale (none, mild, moderate, or severe).
Measured: 1 month
Secondary outcomes (1)
Score on pain due to injection of rocuronium
Withdrawal reactions are scored as follows: (a) no pain response, (b)pain limited to the wrist, (c) pain limited to the elbow/shoulder, or (d) generalized pain response.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start1 Nov 2020
- Primary completion4 Dec 2020
- Study completion4 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injection Site IrritationStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet sahap, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582032
- Sponsor's protocol ID
- roc
- Status last verified
- Jan 2021
- First submitted
- 28 Sep 2020
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of COX 1-2 Inhibitors on Prevention of Rocuronium Injection Pain: Controlled, Randomised, Double Blind Study
- ClinicalTrials.gov ID
- NCT04582032
- Acronym / sponsor ID
- roc
- Conditions
- Injection Site Irritation
- Keywords
- dexketoprofen, pain, rocuronium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 4 Dec 2020 (actual)
- Study completion
- 4 Jan 2021 (actual)
- First posted
- 9 Oct 2020 (actual)
- 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.
Purpose : The aim of the study is to investigate the effects of cox inhibitors as a rescue agent against the rocuronium pain Methodology : Sixty patients enrolled for the general anesthesia enrolled in this study. Patients were allocated into two groups (Group 1: Dexketoprofen group, Group 2: Control group) .Pain was evaluated by during rocuronium injection, patients were scored by a scale showed below.
0;No movement response to injection
- Mild movement response to injection
- Hand withdrawal response to injection
- Arm withdrawal response to injection Investigators also evaluated the pain with 2 questions when the patient was in the recovery room.
Question 1.What was the last feeling before participants fall into sleep? question 2. Did participants feel any pain on participants's hand during medication injection for anesthesia?
Detailed description
Purpose : Rocuronium bromide is a painful agent while general anesthesia induction. The aim of the study is to investigate the effects of cox inhibitors as a rescue agent against the rocuronium pain Methodology : Sixty patients enrolled for the general anesthesia enrolled in this study. Patients were allocated into two groups (Group 1: Dexketoprofen group, Group 2: Control group) .Pain was evaluated by during rocuronium injection, patients were scored by a scale showed below.
0;No movement response to injection
- Mild movement response to injection
- Hand withdrawal response to injection
- Arm withdrawal response to injection Investigators also evaluated the pain with 2 questions when the patient was in the recovery room.
Question 1.What was the last feeling before participants fall into sleep? question 2. Did participants feel any pain on participants's hand during medication injection for anesthesia?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexketoprofen group, | Active comparator | Drug: Dexketoprofen (KETAVEL 50 mg/2 ml)IV cannulation was performed on hand dorsum or brachial and canulation place was recorded. Patients allocated in dexketoprofen group were administered intravenous dexketoprofen (50 mg/2ml) and 0,3 mg/kg midazolam 10 minutes prior to general anesthesia induction |
| Saline group | Other | Drug: Saline (Isotonic Saline Solution 0.9% )IV cannulation was performed on hand dorsum or brachial and canulation place was recorded. Patients allocated in control group were administered intravenous 2 ml of saline and 0,3 mg/kg midazolam 10 minutes prior to general anesthesia induction |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- non allergic to dexketoprofen
- 18-60 years old
- American Society of Anesthesiologists(ASA) 1-2-3
- 70-90 kg weigh
Key exclusion criteria (1 listed)
- patients with psychiatric and mental problems
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 |
|---|---|---|
| Dexketoprofen (KETAVEL 50 mg/2 ml)intravenous dexketoprofen (KETAVEL 50 mg/2 ml) | Drug | Dexketoprofen group, |
| Saline (Isotonic Saline Solution 0.9% )intravenous 2 ml of saline | Drug | Saline group |
Primary outcome
The injection pain due to rocuronium
Time frame: 1 month
Pain will be recorded and graded using a 4-point scale (none, mild, moderate, or severe).
1 secondary outcome
Score on pain due to injection of rocuronium
Time frame: 1 month
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 29 Jan 2021.
- Individual participant dataSharing planned: No
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 study testing Dexketoprofen (KETAVEL 50 mg/2 ml) and Saline (Isotonic Saline Solution 0.9% ) in people with Injection Site Irritation, run by Ankara City Hospital Bilkent 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 4 inclusion and 1 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 29 Jan 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The injection pain due to rocuronium (time frame: 1 month). 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 29 Jan 2021.