Pain After the Surgical Extraction of Third MolarsEarly Phase 1NCT05614440
The Effects of Tramadol Combined With Local Anesthesia on Pain After the Surgical Extraction of Third Molars
A Early Phase 1 study testing Local anesthetic + tramadol hydrochloride and Only local anesthetic in people with Pain After the Surgical Extraction of Third Molars, run by Marmara University.
Trial summary
The purpose of this study was to assess the efficacy of local anesthetic and tramadol combinations in the prevention of pain after the surgical extraction of third molars. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Pain After the Surgical Extraction of Third Molars
- What is being tested?
- Local anesthetic + tramadol hydrochloride and Only local anesthetic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2012to 1 Jan 2014
- Phase
- Early Phase 1
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Score of ASA I-II (American Society of Anesthesiologists Physical Status I or II)
- Patient weights were less than 60 kg
Who cannot join
- Subjects who had taken a sedative, tranquillizer, or analgesic medication within the last 24 h,
- Sensitive to tramadol,
- Patients who needed an extra dose of anesthetic solution during the surgery
About this study
The purpose of this study was to assess the efficacy of local anesthetic and tramadol combinations in the prevention of pain after the surgical extraction of third molars.
Read the detailed description
The surgical removal of impacted third molar teeth is a procedure that is frequently encountered in oral and maxillofacial surgery practices. Pain following these operations is one of the most important factors affecting patient satisfaction. Several pain-management strategies are available. An alternative approach to pain control is to maximize drug levels at the tissue injury site by administering drugs locally.
Tramadol is a centrally acting opioid that provides good analgesia. It reduces the transmission of pain impulses by inhibiting serotonin and norepinephrine re-uptake. In addition to the systemic analgesic effects, the local anesthetic effects of tramadol on the peripheral nerves have been presented in multiple clinical and laboratory studies.
The aim of this study is to test the clinical efficacy of local anesthetic and tramadol combinations during and after the surgical extraction of the lower third molars.
- Being tested
- Local anesthetic + tramadol hydrochloride, Only local anesthetic
- Keywords
- tramadol, third molar extraction, analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local anesthetic + tramadol hydrochlorideDrug
Also called Articaine
Using tramadol hydrochloride and articain HCL for inferior alveolar nerve block
Only local anestheticDrug
Using articain HCL for inferior alveolar nerve block
| Study group | Role | What they receive |
|---|---|---|
| Only local anesthetic group | Active comparator | Not described Receives: Drug: Only local anesthetic |
| Tramadol group | Experimental | Not described Receives: Drug: Local anesthetic + tramadol hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain
Postoperative pain was assessed using a Visual Analogue Scale (VAS) ranging from the absence of pain (score 0) to the most severe pain imaginable. VAS values were taken from the patient during; post-op 10 minutes, hour 1, hour 2, hour 4, hour 6, hour 12, hour 24, hour 48.
Measured: 48 hours
Secondary outcomes (2)
Change in mean blood pressure
Change in mean blood pressure assessed in baseline (after anesthetic injection), minute 10minute, minute 20, minute 30, minute 40, minute 50, minute 60.
Measured: 60 minutes
Change in heart rate
Change in heart rate assessed in baseline (after anesthetic injection), minute 10minute, minute 20, minute 30, minute 40, minute 50, minute 60.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 May 2012
- Primary completion1 Nov 2013
- Study completion1 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pain After the Surgical Extraction of Third MolarsStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The patients were randomly divided into the following two groups using the sealed envelope method.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614440
- Sponsor's protocol ID
- 153-2011
- Status last verified
- Nov 2022
- First submitted
- 31 Oct 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Deshpande AA, Hemavathy OR, Krishnan S, Ahmed R. Comparison of effect of intra socket ketamine and tramadol on postoperative pain after mandibular third molar surgery. Natl J Maxillofac Surg. 2022 Jan-Apr;13(1):95-98. doi: 10.4103/njms.NJMS_141_20. Epub 2022 Apr 20.
PubMed 35911818Vallecillo C, Vallecillo-Rivas M, Galvez R, Vallecillo-Capilla M, Olmedo-Gaya MV. ANALGESIC EFFICACY OF TRAMADOL/DEXKETOPROFEN VS IBUPROFEN AFTER IMPACTED LOWER THIRD MOLAR EXTRACTION: A RANDOMIZED CONTROLLED CLINICAL TRIAL. J Evid Based Dent Pract. 2021 Dec;21(4):101618. doi: 10.1016/j.jebdp.2021.101618. Epub 2021 Jul 28.
PubMed 34922724Iqbal AM, Shetty P. Effect of Submucosal Injection of Tramadol on Postoperative Pain After Third Molar Surgery. J Oral Maxillofac Surg. 2019 Sep;77(9):1752-1759. doi: 10.1016/j.joms.2019.03.029. Epub 2019 Mar 29.
PubMed 31026419Afat IM, Gonul O, Satilmis T. Tramadol combined with local anesthesia for postoperative pain in third molar surgery. BMC Oral Health. 2025 Oct 14;25(1):1610. doi: 10.1186/s12903-025-07011-0.
PubMed 41088090
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Tramadol Combined With Local Anesthesia on Pain After the Surgical Extraction of Third Molars
- ClinicalTrials.gov ID
- NCT05614440
- Acronym / sponsor ID
- 153-2011
- Keywords
- tramadol, third molar extraction, analgesia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 May 2012 (actual)
- Primary completion
- 1 Nov 2013 (actual)
- Study completion
- 1 Jan 2014 (actual)
- First posted
- 14 Nov 2022 (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.
The purpose of this study was to assess the efficacy of local anesthetic and tramadol combinations in the prevention of pain after the surgical extraction of third molars.
Detailed description
The surgical removal of impacted third molar teeth is a procedure that is frequently encountered in oral and maxillofacial surgery practices. Pain following these operations is one of the most important factors affecting patient satisfaction. Several pain-management strategies are available. An alternative approach to pain control is to maximize drug levels at the tissue injury site by administering drugs locally.
Tramadol is a centrally acting opioid that provides good analgesia. It reduces the transmission of pain impulses by inhibiting serotonin and norepinephrine re-uptake. In addition to the systemic analgesic effects, the local anesthetic effects of tramadol on the peripheral nerves have been presented in multiple clinical and laboratory studies.
The aim of this study is to test the clinical efficacy of local anesthetic and tramadol combinations during and after the surgical extraction of the lower third molars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- The patients were randomly divided into the following two groups using the sealed envelope method.
| Arm | Type | Receives |
|---|---|---|
| Only local anesthetic group | Active comparator | Drug: Only local anesthetic |
| Tramadol group | Experimental | Drug: Local anesthetic + tramadol hydrochloride |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Score of ASA I-II (American Society of Anesthesiologists Physical Status I or II)
- Patient weights were less than 60 kg
Key exclusion criteria (3 listed)
- Subjects who had taken a sedative, tranquillizer, or analgesic medication within the last 24 h,
- Sensitive to tramadol,
- Patients who needed an extra dose of anesthetic solution during the surgery
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 |
|---|---|---|
| Local anesthetic + tramadol hydrochlorideAlso: ArticaineUsing tramadol hydrochloride and articain HCL for inferior alveolar nerve block | Drug | Tramadol group |
| Only local anestheticUsing articain HCL for inferior alveolar nerve block | Drug | Only local anesthetic group |
Primary outcome
Change in pain
Time frame: 48 hours
Postoperative pain was assessed using a Visual Analogue Scale (VAS) ranging from the absence of pain (score 0) to the most severe pain imaginable. VAS values were taken from the patient during; post-op 10 minutes, hour 1, hour 2, hour 4, hour 6, hour 12, hour 24, hour 48.
2 secondary outcomes
Change in mean blood pressure
Time frame: 60 minutes
Change in heart rate
Time frame: 60 minutes
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 14 Nov 2022.
- Background: PubMed 35911818Deshpande AA, Hemavathy OR, Krishnan S, Ahmed R. Comparison of effect of intra socket ketamine and tramadol on postoperative pain after mandibular third molar surgery. Natl J Maxillofac Surg. 2022 Jan-Apr;13(1):95-98. doi: 10.4103/njms.NJMS_141_20. Epub 2022 Apr 20.
- Background: PubMed 34922724Vallecillo C, Vallecillo-Rivas M, Galvez R, Vallecillo-Capilla M, Olmedo-Gaya MV. ANALGESIC EFFICACY OF TRAMADOL/DEXKETOPROFEN VS IBUPROFEN AFTER IMPACTED LOWER THIRD MOLAR EXTRACTION: A RANDOMIZED CONTROLLED CLINICAL TRIAL. J Evid Based Dent Pract. 2021 Dec;21(4):101618. doi: 10.1016/j.jebdp.2021.101618. Epub 2021 Jul 28.
- Background: PubMed 31026419Iqbal AM, Shetty P. Effect of Submucosal Injection of Tramadol on Postoperative Pain After Third Molar Surgery. J Oral Maxillofac Surg. 2019 Sep;77(9):1752-1759. doi: 10.1016/j.joms.2019.03.029. Epub 2019 Mar 29.
- Derived from this study: PubMed 41088090Afat IM, Gonul O, Satilmis T. Tramadol combined with local anesthesia for postoperative pain in third molar surgery. BMC Oral Health. 2025 Oct 14;25(1):1610. doi: 10.1186/s12903-025-07011-0.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Local anesthetic + tramadol hydrochloride and Only local anesthetic in people with Pain After the Surgical Extraction of Third Molars, run by Marmara University.
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 2 inclusion and 3 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 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Change in pain (time frame: 48 hours). 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 NCT05614440, which also lists 4 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 14 Nov 2022.