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New treatment option for Acute Pain
Official title Reducing Pain From Wisdom Molar Extractions
ClinicalTrials.gov ID: NCT05335070
What this study is testing
What is Temporo-masseteric Nerve Block?
Temporo-masseteric Nerve Block 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
- This is a pilot study evaluating the ability of the Temporo-masseteric Nerve Block local anesthetic injection (this was called the Twin Block earlier) to reduce pain experienced by individuals undergoing removal of lower third molar(s) under intravenous sedation. Study participants will be queried for pain experience and pain medications taken during the first post-operative week and will present for a follow-up visit on Day 8.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- Age 18 years of age or older (up to 64 years)
- Any demographic
- ASA 1 and 2 (mild or absent systemic illnesses, deemed fit for undergoing dental extractions under intravenous sedation)
- Not pregnant (as will not qualify to undergo procedure under intravenous sedation as part of routine standard-of-care)
- Adequate mental ability to understand and provide informed consent
You likely can't join if
- Age older than 64 years (because they are poor candidates for undergoing procedures under intravenous sedation)
- Pregnant
- Incapable of providing informed consent
- Any systemic condition that renders the patient at higher risk for complications under intravenous sedation
- Documented allergy to the dental local anesthetic
- Inability to tolerate any of the commonly used pain medications such as combination opioids, acetaminophen (Tylenol®) or ibuprofen (Motrin® or Advil®)
See the full eligibility criteria
- Age 18 years of age or older (up to 64 years)
- Any demographic
- ASA 1 and 2 (mild or absent systemic illnesses, deemed fit for undergoing dental extractions under intravenous sedation)
- Not pregnant (as will not qualify to undergo procedure under intravenous sedation as part of routine standard-of-care)
- Adequate mental ability to understand and provide informed consent
- Has smart phone and internet connection
- Age older than 64 years (because they are poor candidates for undergoing procedures under intravenous sedation)
- Pregnant
- Incapable of providing informed consent
- Any systemic condition that renders the patient at higher risk for complications under intravenous sedation
- Documented allergy to the dental local anesthetic
- Inability to tolerate any of the commonly used pain medications such as combination opioids, acetaminophen (Tylenol®) or ibuprofen (Motrin® or Advil®)
- Limitation in adequate mouth opening in presence/absence of pain
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 to 64 years. 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.