Brief Summary
The purpose of the study is to assess if melatonin given for three nights before wisdom tooth surgery decreases post-operative pain and pain medication consumption. Patients will receive either melatonin or a placebo for three nights prior to surgery and we will measure pre-operative anxiety, preoperative sleep quality, post op pain medication consumption, post op pain scores, and blood values.
Brief Title
Preoperative Melatonin to Decrease Analgesia Usage After Third Molar Surgery
Central Contacts
Central Contact Role
Contact
Central Contact Phone
718-904-8190
Central Contact Email
montefioreomfs@gmail.com
Completion Date
Completion Date Type
Estimated
Conditions
Pain, Postoperative
Narcotic Use
Eligibility Criteria
Inclusion Criteria:
* Subject must have 3-4 partial or full bony impacted third molars requiring surgical extraction under IV sedation
* Ages 18-35
* ASA Class I or II
* English or Spanish speaking patients
* Capacity to sign informed consent
Exclusion Criteria:
* Allergies to melatonin, opioids, or other OTC pain medications
* Anyone currently taking melatonin for any reason
* Cases under local anesthesia
* ASA class III or higher
* Sleep disorder (insomnia/narcolepsy)
* Current or past history of substance abuse
* Chronic pain
* Language/communication barrier
* Psychiatric disease/ Mental impairment
* Current or past use of psychotropic drugs
* Pregnancy
* Renal or hepatic impairment
* BMI \>35
* Subject must have 3-4 partial or full bony impacted third molars requiring surgical extraction under IV sedation
* Ages 18-35
* ASA Class I or II
* English or Spanish speaking patients
* Capacity to sign informed consent
Exclusion Criteria:
* Allergies to melatonin, opioids, or other OTC pain medications
* Anyone currently taking melatonin for any reason
* Cases under local anesthesia
* ASA class III or higher
* Sleep disorder (insomnia/narcolepsy)
* Current or past history of substance abuse
* Chronic pain
* Language/communication barrier
* Psychiatric disease/ Mental impairment
* Current or past use of psychotropic drugs
* Pregnancy
* Renal or hepatic impairment
* BMI \>35
Inclusion Criteria
Inclusion Criteria:
* Subject must have 3-4 partial or full bony impacted third molars requiring surgical extraction under IV sedation
* Ages 18-35
* ASA Class I or II
* English or Spanish speaking patients
* Capacity to sign informed consent
* Subject must have 3-4 partial or full bony impacted third molars requiring surgical extraction under IV sedation
* Ages 18-35
* ASA Class I or II
* English or Spanish speaking patients
* Capacity to sign informed consent
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
35 Years
Minimum Age
18 Years
NCT Id
NCT04791943
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2020-12127
Overall Status
Recruiting
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Preoperative Melatonin to Decrease Analgesia Usage After Third Molar Surgery
Primary Outcomes
Outcome Description
The investigators will measure the postoperative consumption of narcotic pain medication consumption. The investigators will measure this for approximately 72 hours post operatively, there are three total surveys and each survey will take about 3 minutes to complete. The surveys will be received via text message or email and link to Surveymonkey. These surveys will come in the morning approximately 1 day after surgery, 2 days after surgery, and 3 days after surgery. The surveys will ask for the participant ID and will then ask how many tablets of ibuprofen 600mg and hydrocodone-acetaminophen have been taken since surgery or the previous survey depending on if the survey is received on day 1 versus 2 and 3.
Outcome Measure
Postoperative narcotic consumption
Outcome Time Frame
We will measure this and participants will complete the above mentioned survey. From the time participants are enrolled in the study, to completion of these surveys will take about 2-4 weeks.
Secondary Outcomes
Outcome Description
The investigators will measure blood levels of IL6, IL8, TNF-alpha, and CRP to try and estimate the systemic inflammatory response.
Outcome Time Frame
Blood draws at the consultation, surgery day, and at the 5 day post operative visit (~2-4 week window).
Outcome Measure
Inflammatory markers
Outcome Description
Patients will fill out a survey to estimate their anxiety levels immediately before surgery. The investigators will measure this immediately before surgery with a survey. The survey will ask a series of 4 questions about anxiety and 1 question about sleep quality. Participants will be asked to described their anxiety on a scale of approximately 1 to 5 (1 not at all, 5 extremely highly) in relation to how worried they are about the procedure and anesthetic as well as how often they think about the procedure and anesthetic. The last question about sleep asks the participants to describe their sleep quality during the three nights prior to surgery on a scale of 1 to 5 (1 most improved, 5 much worse).
Outcome Time Frame
On day of surgery the patients will fill out a short survey, described above. This survey will be given on the day of surgery, 2-4 weeks after enrollment.
Outcome Measure
Preoperative Anxiety
Outcome Description
Patients will complete a survey and describe their pain levels on a scale 0-100. The investigators will measure this for approximately 72 hours post operatively, there are four total surveys and each survey will take about 2 minutes to complete. The surveys will be received via text message or email and link to Surveymonkey. These surveys will come in the morning approximately 1 day after surgery, 2 days after surgery, 3 days after surgery and the last survey will be administered on paper at the postoperative follow up, day 5. The surveys will ask for the participant ID and will then ask the participant to describe their worst pain they have experienced since surgery or the previous survey depending on if the survey is received on day 1 versus 2, 3, and 5.
Outcome Time Frame
Patients will fill out a short survey, described above. From the time participants are enrolled in the study, to completion of these surveys will take about 2-4 weeks.
Outcome Measure
Post operative pain
Outcome Description
The heart rate will be measured at the consultation and surgery appointment for comparison between groups.
Outcome Time Frame
Heart rate will be measured two times, once at the consultation and again at the surgery appointment 2-4 weeks later.
Outcome Measure
Heart Rate
Outcome Description
The mean arterial pressure (MAP) will be measured at the consultation and surgery appointment for comparison between groups.
Outcome Time Frame
MAP will be measured two times, once at the consultation and again at the surgery appointment 2-4 weeks later.
Outcome Measure
Blood Pressure
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
35
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jason Baker
Investigator Email
jabaker@montefiore.org
Investigator Sponsor Organization
Montefiore
Study Department
Dentistry
Study Division
Oral & Maxillofacial Surgery
Categories Mesh Debug
Brain, Spinal Cord & Nervous System --- PAIN
Headaches & Migraine --- PAIN
Brain, Spinal Cord & Nervous System --- NEUROLOGIC MANIFESTATIONS
Headaches & Migraine --- NEUROLOGIC MANIFESTATIONS
Substance Use and Addiction --- NEUROLOGIC MANIFESTATIONS
MeSH Terms
PAIN, POSTOPERATIVE
POSTOPERATIVE COMPLICATIONS
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
PAIN
NEUROLOGIC MANIFESTATIONS
SIGNS AND SYMPTOMS
MELATONIN
LACTOSE
TRYPTAMINES
INDOLES
HETEROCYCLIC COMPOUNDS, 2-RING
HETEROCYCLIC COMPOUNDS, FUSED-RING
HETEROCYCLIC COMPOUNDS
HORMONES
HORMONES, HORMONE SUBSTITUTES, AND HORMONE ANTAGONISTS
DISACCHARIDES
OLIGOSACCHARIDES
POLYSACCHARIDES
CARBOHYDRATES
SUGARS