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New treatment option for Acute Pain
Official title Twin Block, Pain Medications and Third Molar Extractions
ClinicalTrials.gov ID: NCT04880707
What this study is testing
What is Twin block local anesthetic nerve block using standard dental anesthetic?
Twin block local anesthetic nerve block using standard dental anesthetic is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for acute pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Each year, over 3.5 million, mostly, healthy young adults, have their third molar teeth ('wisdom teeth') removed under sedation and are often given opioid prescriptions for managing their pain. Wisdom molar removal is one of the most common reasons for opioid prescriptions to be given to adolescents.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- All patients requiring extraction/s of at least 1 lower wisdom (third) molar that is partially/fully 'impacted', under intravenous sedation, are...
- are older than 18 years of age,
- are healthy,
- have no cognitive/intellectual disability,
- have no past/recent pain or reduced range of motion in their jaw joint/ muscle complex, no trauma or surgery in their jaw region.
You likely can't join if
- Any patients, even if satisfying the criteria above, may not take part if they have any of the following:
- Compromised ability to guard their self-interest, for e.g., prisoners, children, pregnant women, patients with intellectual/cognitive disability are...
- Those patients who present with infection/inflammation involving the third molars slated for extractions, on the day of their procedure, may not take...
- In addition, those who have had opioid pain medication/s in the past to address short-term or long-standing pain, or those who are on long term...
- Those with long standing pain of the jaw joint or muscles.
- Finally, those patients who are allergic to/unable to tolerate either the dental local anesthetic or its components, opioids, acetaminophen...
See the full eligibility criteria
- All patients requiring extraction/s of at least 1 lower wisdom (third) molar that is partially/fully 'impacted', under intravenous sedation, are eligible to participate in this study so long as they
- are older than 18 years of age,
- are healthy,
- have no cognitive/intellectual disability,
- have no past/recent pain or reduced range of motion in their jaw joint/ muscle complex, no trauma or surgery in their jaw region.
- have an electronic device such as a smart phone or a tablet/ computer with internet connection.
- are willing to participate in the study and not be excluded by the following criteria below.
- Any patients, even if satisfying the criteria above, may not take part if they have any of the following:
- Compromised ability to guard their self-interest, for e.g., prisoners, children, pregnant women, patients with intellectual/cognitive disability are not enrolled in the study.
- Those patients who present with infection/inflammation involving the third molars slated for extractions, on the day of their procedure, may not take part in the study.
- In addition, those who have had opioid pain medication/s in the past to address short-term or long-standing pain, or those who are on long term prescription of anti-inflammatory pain medication, are unable to...
- Those with long standing pain of the jaw joint or muscles.
- Finally, those patients who are allergic to/unable to tolerate either the dental local anesthetic or its components, opioids, acetaminophen ('Tylenol') or ibuprofen ('Motrin' or 'Advil') also may not take part in the...
The study team makes the final eligibility decision.
Where it's taking place
- Newark, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Newark, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.