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Gabapentin for Dental Pain
Study Summary
This trial is testing whether gabapentin can reduce pain and the need for painkillers after wisdom teeth removal.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 4 trial • 121 Patients • NCT03080493Trial Design
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- I do not have any mouth diseases.I have not had a serious illness or condition in the last 14 days.You are in good health according to your doctor's evaluation.I have been using opioids or gabapentin regularly for more than 3 months.You are allergic to gabapentinoids.I need to have at least one wisdom tooth removed.I am legally able to give consent for medical treatment.I am 18 years old or older.Your body mass index (BMI) is between 18 and 35.You have used recreational drugs in the past.I experience pain regularly.Your body mass index (BMI) is between 18 and 35.You are in good health according to your doctor's assessment.I am 18 years old or older.I need to have at least one wisdom tooth removed.Subjects must be able to understand the informed consent and must be able to sign a written informed consent form prior to the initiation of any study procedures.
- Group 1: Gabapentin group
- Group 2: Placebo group
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What criteria must potential participants meet to be eligible for this medical experiment?
"The criteria for enrolment in this trial is the presence of post-operative pain, a patient's age ranging between 18 and 59 years old. The research team seeks to recruit 98 participants."
What is the ultimate intent of this medical experiment?
"Over a 72 hour postoperative period, the primary outcome of this clinical trial will be evaluated according to intraoperative fentanyl use. Secondary outcomes include pain interfering in normal work (scale 0-10), pain interfering in relations with other people (scale 0-10) and pain interfering in general activity (scale 0-10)."
What ailments are commonly addressed by the administration of Gabapentin 600mg?
"Gabapentin 600mg is a successful therapeutic option for managing neuralgia, epilepsies and postherpetic neuralgia."
To what extent has Gabapentin 600mg been tested in other clinical studies?
"At the moment, 25 studies revolving around Gabapentin 600mg are underway. Of these trials, 9 have reached Phase 3. The bulk of them are based in Columbus, Ohio but they span across 67 different locations globally."
Are the elderly being admitted to this clinical experiment?
"This study is limited to participants aged between 18 and 59. For those outside this age range, there are 76 trials available for minors and 392 studies aimed at seniors."
Does this experiment still accept participants?
"Affirmative. The clinicaltrial.gov record confirms that the study, which was initially published in June 2021, is presently recruiting participants; 98 people are needed from 1 medical facility."
What is the participant recruitment rate for this research endeavor?
"Affirmative. Clinicaltrials.gov's data states that the investigation, which was first detailed on June 16th 2021, is still searching for participants. The trial requires 98 subjects to be enrolled at one facility."
What are the potential hazards associated with Gabapentin 600mg?
"Taking into account the fact that this is a Phase 4 trial and has already been approved, our team at Power gave Gabapentin 600mg a rating of 3 in terms of safety."
Who else is applying?
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