Preemptive Intravenous IbuprofenNCT03170726
Impact of Preemptive Intravenous Ibuprofen on Intraoperative Analgesia in Third Molar Teeth
A study testing arveles, intrafen 800 mg and plasebos in people with Preemptive Intravenous Ibuprofen and Intraoperative Analgesia, run by Erzincan University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to evaluate the analgesic efficacy of preemptive intravenous (iv) ibuprofen on pain occurring during and after the mandibular third molar surgeon Read more about this study
- Who is it for?
- Ages 20 to 35 years
- Conditions the study is for
- Preemptive Intravenous Ibuprofen, Intraoperative Analgesia
- What is being tested?
- arveles, intrafen 800 mg and plasebos
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2017to 15 Nov 2017
- 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 20 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who are to be elected third molar tooth extraction
- Patients between the ages of 20-35
- Patients who are symptomatic
- Third molar tooth angular or horizontal settled patients
Who cannot join
- Patients who refuse to participate in the study
- Patients under 20 years old, over 35 years old
- Patients who are allergic to known non-steroidal anti-inflammatory drugs
- Pregnant patients
- Patients with severe liver failure,
- patients with severe renal insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
This study was planned to evaluate the analgesic efficacy of preemptive intravenous (iv) ibuprofen on pain occurring during and after the mandibular third molar surgeon
- Being tested
- arveles, intrafen 800 mg, plasebos
- Keywords
- Preemptive intravenous ibuprofen, Intraoperative analgesia, Third molar tooth surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arvelesDrug
Also called dexketoprofen
Intraoperative and postoperative pain values between these three groups will be compared.
intrafen 800 mgDrug
Also called ibuprofen i.v.
ibuprofen 800 mg in normal saline 150 cc before operation will be given in 30 minutes. Intraoperative and postoperative pain values between these three groups will be compared.
plasebosOther
normal saline 150 cc before operation will be given in 30 minutes. Intraoperative and postoperative pain values between these three groups will be compared.
| Study group | Role | What they receive |
|---|---|---|
| arveles | Active comparator | Ibuprofen 800 mg in normal saline 150 cc and dexketoprofen (50 mg) before operation will be given in 30 minutes Receives: Drug: arveles; Drug: intrafen 800 mg; Other: plasebos |
| intrafen | Active comparator | intrafen 800 mg in normal saline 150 cc before operation will be given in 30 minutes Receives: Drug: arveles; Drug: intrafen 800 mg; Other: plasebos |
| plasebos | Placebo comparator | 150 cc normal saline will be given in 30 minutes during preoperative period Receives: Drug: arveles; Drug: intrafen 800 mg; Other: plasebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative pain as assessed by visual analogue scale
Assessment of Preemptive intravenous ibuprofen on intraoperative analgesic efficacy in 3. molar tooth extraction
Measured: 5 month
Secondary outcomes (1)
postoperative pain as assessed by visual analogue scale
postoperative analgesic contribution of preemptively administered intravenous ibuprofen.
Measured: 5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start15 May 2017
- Primary completion30 Oct 2017 (estimated)
- Study completion15 Nov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Preemptive Intravenous IbuprofenStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ILKE KUPELI, Erzincan University
- Investigators
- ilke kupeli, Principal investigator, Erzincan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170726
- Sponsor's protocol ID
- ERZINCAN UNIVERSITY 9
- Status last verified
- May 2017
- First submitted
- 20 May 2017
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jerjes W, El-Maaytah M, Swinson B, Banu B, Upile T, D'Sa S, Al-Khawalde M, Chaib B, Hopper C. Experience versus complication rate in third molar surgery. Head Face Med. 2006 May 25;2:14. doi: 10.1186/1746-160X-2-14.
PubMed 16725024Oscier CD, Milner QJ. Peri-operative use of paracetamol. Anaesthesia. 2009 Jan;64(1):65-72. doi: 10.1111/j.1365-2044.2008.05674.x.
PubMed 19087009Hariharan S, Moseley H, Kumar A, Raju S. The effect of preemptive analgesia in postoperative pain relief--a prospective double-blind randomized study. Pain Med. 2009 Jan;10(1):49-53. doi: 10.1111/j.1526-4637.2008.00547.x.
PubMed 19222770Trampitsch E, Pipam W, Moertl M, Sadjak A, Dorn C, Sittl R, Likar R. [Preemptive randomized, double-blind study with lornoxicam in gynecological surgery]. Schmerz. 2003 Jan;17(1):4-10. doi: 10.1007/s00482-001-0129-7. German.
PubMed 12579384Buvanendran A, Kroin JS. Multimodal analgesia for controlling acute postoperative pain. Curr Opin Anaesthesiol. 2009 Oct;22(5):588-93. doi: 10.1097/ACO.0b013e328330373a.
PubMed 19606021
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preemptive Intravenous Ibuprofen on Intraoperative Analgesia in Third Molar Teeth
- ClinicalTrials.gov ID
- NCT03170726
- Acronym / sponsor ID
- ERZINCAN UNIVERSITY 9
- Keywords
- Preemptive intravenous ibuprofen, Intraoperative analgesia, Third molar tooth surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 30 Oct 2017 (estimated)
- Study completion
- 15 Nov 2017 (estimated)
- First posted
- 31 May 2017 (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.
This study was planned to evaluate the analgesic efficacy of preemptive intravenous (iv) ibuprofen on pain occurring during and after the mandibular third molar surgeon
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| arveles | Active comparator | Drug: arveles, Drug: intrafen 800 mg, Other: plasebosIbuprofen 800 mg in normal saline 150 cc and dexketoprofen (50 mg) before operation will be given in 30 minutes |
| intrafen | Active comparator | Drug: arveles, Drug: intrafen 800 mg, Other: plasebosintrafen 800 mg in normal saline 150 cc before operation will be given in 30 minutes |
| plasebos | Placebo comparator | Drug: arveles, Drug: intrafen 800 mg, Other: plasebos150 cc normal saline will be given in 30 minutes during preoperative period |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients who are to be elected third molar tooth extraction
- Patients between the ages of 20-35
- Patients who are symptomatic
- Third molar tooth angular or horizontal settled patients
Key exclusion criteria (6 listed)
- Patients who refuse to participate in the study
- Patients under 20 years old, over 35 years old
- Patients who are allergic to known non-steroidal anti-inflammatory drugs
- Pregnant patients
- Patients with severe liver failure,
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 |
|---|---|---|
| arvelesAlso: dexketoprofenIntraoperative and postoperative pain values between these three groups will be compared. | Drug | arveles, intrafen, plasebos |
| intrafen 800 mgAlso: ibuprofen i.v.ibuprofen 800 mg in normal saline 150 cc before operation will be given in 30 minutes. Intraoperative and postoperative pain values between these three groups will be compared. | Drug | arveles, intrafen, plasebos |
| plasebosnormal saline 150 cc before operation will be given in 30 minutes. Intraoperative and postoperative pain values between these three groups will be compared. | Other | arveles, intrafen, plasebos |
Primary outcome
intraoperative pain as assessed by visual analogue scale
Time frame: 5 month
Assessment of Preemptive intravenous ibuprofen on intraoperative analgesic efficacy in 3. molar tooth extraction
1 secondary outcome
postoperative pain as assessed by visual analogue scale
Time frame: 5 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Background: PubMed 16725024Jerjes W, El-Maaytah M, Swinson B, Banu B, Upile T, D'Sa S, Al-Khawalde M, Chaib B, Hopper C. Experience versus complication rate in third molar surgery. Head Face Med. 2006 May 25;2:14. doi: 10.1186/1746-160X-2-14.
- Background: PubMed 19087009Oscier CD, Milner QJ. Peri-operative use of paracetamol. Anaesthesia. 2009 Jan;64(1):65-72. doi: 10.1111/j.1365-2044.2008.05674.x.
- Background: PubMed 19222770Hariharan S, Moseley H, Kumar A, Raju S. The effect of preemptive analgesia in postoperative pain relief--a prospective double-blind randomized study. Pain Med. 2009 Jan;10(1):49-53. doi: 10.1111/j.1526-4637.2008.00547.x.
- Results publication: PubMed 12579384Trampitsch E, Pipam W, Moertl M, Sadjak A, Dorn C, Sittl R, Likar R. [Preemptive randomized, double-blind study with lornoxicam in gynecological surgery]. Schmerz. 2003 Jan;17(1):4-10. doi: 10.1007/s00482-001-0129-7. German.
- Results publication: PubMed 19606021Buvanendran A, Kroin JS. Multimodal analgesia for controlling acute postoperative pain. Curr Opin Anaesthesiol. 2009 Oct;22(5):588-93. doi: 10.1097/ACO.0b013e328330373a.
- 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.
ilke kupeli principal investigator
Erzincan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing arveles, intrafen 800 mg and plasebos in people with Preemptive Intravenous Ibuprofen and Intraoperative Analgesia, run by Erzincan 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 31 May 2017. 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.
Are results available for this study?
Results are not available in the source record.
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?
intraoperative pain as assessed by visual analogue scale (time frame: 5 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03170726, which also lists 5 linked publications.
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 31 May 2017.