Pain, Post-operativeEarly Phase 1NCT06484439
Controlled Trial to Determine Most Effective Post-Operative Analgesia After Third Molar Extraction
A Early Phase 1 study testing Ketorolac, Oxycodone and Acetaminophen in people with Pain, Post-operative and Third Molar, run by United States Naval Medical Center, San Diego at 1 site in United States.
Trial summary
This is a prospective randomized clinical trial that will investigate which post-operative medications in conjunction with a multimodal analgesia approach can most effectively control post-operative pain and reduce opioid consumption. Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Post-operative, Third Molar, Oral Surgery
- What is being tested?
- Ketorolac, Oxycodone and Acetaminophen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2018to 1 Dec 2021
- 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 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female 18 years or older
- Scheduled for 3rd molar extraction (x4) with at least one mandibular 3rd molar impacted
- American Society of Anesthesiologists classification 1 or 2
- Able to provide consent, adhere to study schedule, complete study journal, and understand English
Who cannot join
- History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics or opioids
- Contraindication to lidocaine, epinephrine, bupivacaine, or hydrocodone
- Significant drug allergy history
- Currently pregnant or nursing at time of study or within 1 month of drug administration
- Severe renal or hepatic impairment, significant cardiovascular disease; migraines, frequent headaches.
- Use of any of the following medication within 1 month of EXPAREL infiltration or if the medications are being given to control pain: Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Nonadrenaline Reuptake Inhibitors (SNRIs), gabapentin, pregabalin, or duloxetine.
- Current use of systemic glucocorticosteroids within 1 month of enrollment in the study
- No concurrent surgical procedures within 2 weeks before or after 3rd molar extractions
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Medical Center San Diego
San Diego, California, 92134
About this study
Official title: "A Prospective Randomized Controlled Trial to Determine Most Effective Post-Operative Analgesia After Third Molar Extraction"
This is a prospective randomized clinical trial that will investigate which post-operative medications in conjunction with a multimodal analgesia approach can most effectively control post-operative pain and reduce opioid consumption.
Read the detailed description
The recruitment of patients is covered in another section. Once patients are recruited based on inclusion/exclusion criteria, they will be consented and randomized into one of the 2 arms. The pre and perioperative anesthesia protocols will be identical for each arm and will consist of an opioid free general anesthesia. Local anesthesia will be given in an identical fashion in all arms. One cartridge of 2% lidocaine with 1:100k epinephrine will be given as a nerve block for the inferior alveolar nerve bilaterally. Then one cartridge of 0.5% bupivacaine with 1:200k epinephrine will be locally injected for at each of the four 3rd molar sites. Both arms will be injected with 133mg (10cc) of liposomal bupivacaine. The third molars will then be extracted in typical fashion. Each patient will be attached to one of two postoperative arms distinguished by the post-operative medications received. The control arm will be 650 mg Tylenol PO scheduled q6h, 600mg Motrin per os (PO) scheduled q6h and 5 mg hydrocodone PO pro re nata (PRN) q6h. The study arm will be 10 mg Toradol PO q6h, 650 mg acetaminophen PO scheduled q6h, and 5 mg oxycodone PO PRN q6h. The blinded medication will be either the 600mg Motrin or the 10mg Toradol. The patients will be standard 3rd molar extraction post-operative instructions as well as specific instructions on how to take medications. The identity of the patients will be linked to a key that will be kept in a locked box inside a keypad entry office. All future pain assessors will be blinded to the arm of the study in which the patient is attached. The patients will respond to daily pain intensity scores, medications taken, quality of life measures through a survey. The patients will be taught about the surveys during the consent process and again postoperatively. An email or phone will be done for the patients on the following morning for the first 5 days postoperatively. The patient will be instructed to complete the survey that will assess pain, medications taken and quality of life items. The patients will submit these daily until they return to clinic 5 days post-op where they will again submit one survey collectively discussing the outcomes of the previous 5 days. All arms will have the primary investigator's cell phone number if any adverse reactions present themselves.
- Conditions
- Pain, Post-operative, Third Molar, Oral Surgery, Pain, Acute
- Being tested
- Ketorolac, Oxycodone, Acetaminophen, Ibuprofen, Hydrocodone
- Medical subject headings
- Pain, Postoperative, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
Also called Toradol
10 mg PO q 6h scheduled
OxycodoneDrug
Also called Oxycontin
5 mg PO PRN
AcetaminophenDrug
Also called Tylenol
650 mg q 6h scheduled
IbuprofenDrug
Also called Motrin
600 mg PO scheduled q6h
HydrocodoneDrug
Also called Vicodin
5 mg hydrocodone PO PRN q6h
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen, Ibuprofen, Hydrocodone Control arm | Active comparator | The control arm will be 650 mg Acetaminophen PO scheduled q6h, 600mg Ibuprofen PO scheduled q6h and 5 mg Hydrocodone PO PRN q6h. Receives: Drug: Acetaminophen; Drug: Ibuprofen; Drug: Hydrocodone |
| Ketorolac, Acetaminophen, Oxycodone Study arm | Experimental | The study arm will be 10 mg Ketorolac PO q6h, 650 mg Acetaminophen PO scheduled q6h, and 5 mg Oxycodone PO PRN q6h. Receives: Drug: Ketorolac; Drug: Oxycodone; Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain control after third molar extraction
All participants will complete a daily survey on the medications taken to relieve pain.
Measured: Up to five days post operative procedure.
Post operative opioid use after third molar extraction
Daily survey will be used to assess the amount of post operative opioid us including dosage and frequency of use.
Measured: Up to five days post operative procedure.
Post operative pain assessment after third molar extraction
Participants fill out daily for five days post operative procedure the Numeric Pain Rating Scale (NPRS). This is a ten point scale with 0 = No pain, 5 = Moderate pain, 10 = Worst possible pain. The higher the number is a worse outcome.
Measured: Up to five days post operative procedure.
Post operative quality of life assessment after third molar extraction
Post operative quality of life was ascertained with the 10 point Likert scaled question, "What is your rating for your actual overall comfort?'. 1 = Very low overall comfort, 5 = Neither low or high overall comfort, 10 = Very high overall comfort.
The higher the score means a better outcome. This question is part of the daily survey that participants filled out for five days post operative procedure.
Measured: Up to five days after third molar extraction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start14 Feb 2018
- Primary completion3 Nov 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, Post-operativeStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Patrick Morrell, United States Naval Medical Center, San Diego
- Investigators
- Patrick T Morrell, DMD, Principal investigator, United States Naval Medical Center, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484439
- Sponsor's protocol ID
- NMCSD.2018.0014
- Status last verified
- Jul 2024
- First submitted
- 4 Jun 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "A Prospective Randomized Controlled Trial to Determine Most Effective Post-Operative Analgesia After Third Molar Extraction"
- ClinicalTrials.gov ID
- NCT06484439
- Acronym / sponsor ID
- NMCSD.2018.0014
- Conditions
- Pain, Post-operative, Third Molar, Oral Surgery, Pain, Acute
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 3 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 3 Jul 2024 (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 is a prospective randomized clinical trial that will investigate which post-operative medications in conjunction with a multimodal analgesia approach can most effectively control post-operative pain and reduce opioid consumption.
Detailed description
The recruitment of patients is covered in another section. Once patients are recruited based on inclusion/exclusion criteria, they will be consented and randomized into one of the 2 arms. The pre and perioperative anesthesia protocols will be identical for each arm and will consist of an opioid free general anesthesia. Local anesthesia will be given in an identical fashion in all arms. One cartridge of 2% lidocaine with 1:100k epinephrine will be given as a nerve block for the inferior alveolar nerve bilaterally. Then one cartridge of 0.5% bupivacaine with 1:200k epinephrine will be locally injected for at each of the four 3rd molar sites. Both arms will be injected with 133mg (10cc) of liposomal bupivacaine. The third molars will then be extracted in typical fashion. Each patient will be attached to one of two postoperative arms distinguished by the post-operative medications received. The control arm will be 650 mg Tylenol PO scheduled q6h, 600mg Motrin per os (PO) scheduled q6h and 5 mg hydrocodone PO pro re nata (PRN) q6h. The study arm will be 10 mg Toradol PO q6h, 650 mg acetaminophen PO scheduled q6h, and 5 mg oxycodone PO PRN q6h. The blinded medication will be either the 600mg Motrin or the 10mg Toradol. The patients will be standard 3rd molar extraction post-operative instructions as well as specific instructions on how to take medications. The identity of the patients will be linked to a key that will be kept in a locked box inside a keypad entry office. All future pain assessors will be blinded to the arm of the study in which the patient is attached. The patients will respond to daily pain intensity scores, medications taken, quality of life measures through a survey. The patients will be taught about the surveys during the consent process and again postoperatively. An email or phone will be done for the patients on the following morning for the first 5 days postoperatively. The patient will be instructed to complete the survey that will assess pain, medications taken and quality of life items. The patients will submit these daily until they return to clinic 5 days post-op where they will again submit one survey collectively discussing the outcomes of the previous 5 days. All arms will have the primary investigator's cell phone number if any adverse reactions present themselves.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen, Ibuprofen, Hydrocodone Control arm | Active comparator | Drug: Acetaminophen, Drug: Ibuprofen, Drug: HydrocodoneThe control arm will be 650 mg Acetaminophen PO scheduled q6h, 600mg Ibuprofen PO scheduled q6h and 5 mg Hydrocodone PO PRN q6h. |
| Ketorolac, Acetaminophen, Oxycodone Study arm | Experimental | Drug: Ketorolac, Drug: Oxycodone, Drug: AcetaminophenThe study arm will be 10 mg Ketorolac PO q6h, 650 mg Acetaminophen PO scheduled q6h, and 5 mg Oxycodone PO PRN q6h. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female 18 years or older
- Scheduled for 3rd molar extraction (x4) with at least one mandibular 3rd molar impacted
- American Society of Anesthesiologists classification 1 or 2
- Able to provide consent, adhere to study schedule, complete study journal, and understand English
Key exclusion criteria (8 listed)
- History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics or opioids
- Contraindication to lidocaine, epinephrine, bupivacaine, or hydrocodone
- Significant drug allergy history
- Currently pregnant or nursing at time of study or within 1 month of drug administration
- Severe renal or hepatic impairment, significant cardiovascular disease; migraines, frequent headaches.
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 |
|---|---|---|
| KetorolacAlso: Toradol10 mg PO q 6h scheduled | Drug | Ketorolac, Acetaminophen, Oxycodone Study arm |
| OxycodoneAlso: Oxycontin5 mg PO PRN | Drug | Ketorolac, Acetaminophen, Oxycodone Study arm |
| AcetaminophenAlso: Tylenol650 mg q 6h scheduled | Drug | Acetaminophen, Ibuprofen, Hydrocodone Control arm, Ketorolac, Acetaminophen, Oxycodone Study arm |
| IbuprofenAlso: Motrin600 mg PO scheduled q6h | Drug | Acetaminophen, Ibuprofen, Hydrocodone Control arm |
| HydrocodoneAlso: Vicodin5 mg hydrocodone PO PRN q6h | Drug | Acetaminophen, Ibuprofen, Hydrocodone Control arm |
Primary outcome
Post operative pain control after third molar extraction
Time frame: Up to five days post operative procedure.
All participants will complete a daily survey on the medications taken to relieve pain.
Post operative opioid use after third molar extraction
Time frame: Up to five days post operative procedure.
Daily survey will be used to assess the amount of post operative opioid us including dosage and frequency of use.
Post operative pain assessment after third molar extraction
Time frame: Up to five days post operative procedure.
Participants fill out daily for five days post operative procedure the Numeric Pain Rating Scale (NPRS). This is a ten point scale with 0 = No pain, 5 = Moderate pain, 10 = Worst possible pain. The higher the number is a worse outcome.
Post operative quality of life assessment after third molar extraction
Time frame: Up to five days after third molar extraction.
Post operative quality of life was ascertained with the 10 point Likert scaled question, "What is your rating for your actual overall comfort?'. 1 = Very low overall comfort, 5 = Neither low or high overall comfort, 10 = Very high overall comfort. The higher the score means a better outcome. This question is part of the daily survey that participants filled out for five days post operative procedure.
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 10 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Pain, Post-operative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Patrick T Morrell, DMD principal investigator
United States Naval Medical Center, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ketorolac, Oxycodone and Acetaminophen in people with Pain, Post-operative and Third Molar, run by United States Naval Medical Center, San Diego at 1 site in United States.
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 8 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 10 Jul 2024. 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 United States. 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.
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?
Post operative pain control after third molar extraction (time frame: Up to five days post operative procedure.). The study lists 4 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 10 Jul 2024.