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| Name | Class |
|---|---|
| Quest Diagnostics-Nichols Insitute | INDUSTRY |
| Eurofins Viracor | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Treatment - Melatonin | Experimental | Premedication for three nights with 10mg melatonin |
|
| Control Treatment - Lactose | Placebo Comparator | Premedication for three nights with lactose capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin 10 MG | Drug | 3 melatonin 10mg capsules will be given to the treatment arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative narcotic consumption | Postoperative consumption of narcotic pain medication will be measured for approximately 72 hours post operatively. Three total surveys will be administered. The surveys will be sent to participants via text message or email and include a link to SurveyMonkey. These surveys will be sent in the morning approximately 1 day, 2 days, and 3 days after surgery. The surveys will query for participant identification and then ask how many tablets of ibuprofen 600mg and hydrocodone-acetaminophen have been taken since the time of surgery or the time of previous survey depending on if the survey is received on Day 1, versus Day 2, and Day 3. The number of narcotic pain medication pills consumed postoperatively will be presented as means and standard deviations by treatment arm. | From the time of intervention to the completion of the surveys, approximately 2-4 weeks total |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory cytokine markers - IL-6, IL-8, TNF-alpha concentrations | Preoperative and postoperative blood draws will be taken to measure concentrations of the inflammatory biomarkers Interleukin-6 (IL-6), Interleukin-6 (IL-8), and Tumor Necrosis Factor-alpha (TNF-alpha) to estimate systemic inflammatory response. Two sets of preoperative blood draws will be obtained. The first set (preoperative) will be drawn following consent during consultation. The second set (immediate preoperative) will be drawn just prior to the operation on Day 0. Participants will return to the office on postoperative day five (POD5) to have blood drawn for the third set of blood draws (postoperative). Concentrations for each of the inflammatory cytokines (IL-6, IL-8, and TNF- alpha) will be reported in pg/mL and results at each timepoint will be summarized by study arm using basic descriptive statistics. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Baker, DMD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center Department of Dentistry | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23410617 | Background | Jones CM. Heroin use and heroin use risk behaviors among nonmedical users of prescription opioid pain relievers - United States, 2002-2004 and 2008-2010. Drug Alcohol Depend. 2013 Sep 1;132(1-2):95-100. doi: 10.1016/j.drugalcdep.2013.01.007. Epub 2013 Feb 12. | |
| 24871348 | Background | Cicero TJ, Ellis MS, Surratt HL, Kurtz SP. The changing face of heroin use in the United States: a retrospective analysis of the past 50 years. JAMA Psychiatry. 2014 Jul 1;71(7):821-6. doi: 10.1001/jamapsychiatry.2014.366. |
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IPD will not be shared with other researchers.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| D007785 | Lactose |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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A randomization list using a variable block size will be prepared by the study biostatistician. The lists of treatment assignments (1:1 ratio) will be kept on file.
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The surgeon and the patient will be masked, the research coordinator will not be masked.
| Lactose pill | Drug | 3 lactose pills will be provided to the control arm |
|
| Blood draws during consultation, immediately prior to surgery, and at POD5, approximately 2-4 weeks total |
| Inflammatory markers - CRP concentrations | Preoperative and postoperative blood draws will be taken to measure concentrations of C-reactive protein (CRP). CRP is produced by the liver in response to pro-inflammatory cytokines released during inflammation. Two sets of preoperative blood draws will be obtained. The first set (preoperative) will be drawn following consent during consultation. The second set (immediate preoperative) will be drawn just prior to the operation on Day 0. Participants will return to the office on postoperative day five (POD5) to have blood drawn for the third set of blood draws (postoperative). CRP concentration will be reported in mg/L and results at each timepoint will be summarized by study arm using basic descriptive statistics. | Blood draws during consultation, immediately prior to surgery, and at POD5, approximately 2-4 weeks total |
| Preoperative Anxiety | Preoperative anxiety will be assessed using an Anxiolysis Questionnaire modeled on the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Participants will complete the survey to describe anxiety levels immediately before surgery. This survey consists of 4 questions which asks participants to rate each item on a scale of 1 ("Not at all") to 5 ("Extremely" or "Extremely highly") to best describe how worried they are about the procedure and anesthetic as well as how often they think about the procedure and anesthetic. Higher scores are associated with increasing levels of anxiety with a total score of >=11 considered a key anxiety threshold. Scores will be summarized and reported using basic descriptive statistics. | On the day of surgery prior to the procedure, approximately 2-4 weeks after enrollment |
| Preoperative Sleep Quality | Sleep quality over the previous three nights while taking the premedication immediately before surgery will be assessed based on a survey response. Specifically, participants will be administered a survey and asked to rate their quality of sleep during the three nights prior to surgery on a scale of 1 ("Much improved") to 5 ("Much worse") such that lower scores are associated with increased sleep quality. Sleep quality results will be presented as frequencies (percentages). | On the day of surgery prior to the procedure, approximately 2-4 weeks after enrollment |
| Post operative pain | Post operative pain will be assessed using a Visual Analog Scale (VAS). The VAS is a unidimensional tool for measuring pain intensity. Participants will be administered a total of four surveys via text message or email with a link to SurveyMonkey. These surveys will be sent approximately 1 day, 2 days, and 3 days following surgery and will take about 2 minutes to complete. The last survey will be administered on paper during postoperative follow up, on POD5. The surveys will query for participant ID and then ask participants to describe the worst pain they have experienced since the surgery or since the previous survey depending on day administered, using the VAS. Responses for the VAS can range from 0-100 wherein 0 = "No pain" and 100 = "Worst pain imaginable" such that higher scores are indicative of greater pain intensity. Cut points on the VAS include "Mild" (1-30), "Moderate" (31-70) and "Severe" (71-100). Pain scores will be summarized using basic descriptive statistics. | The morning of the first 3 postoperative days (approximately 72 hours postoperatively) and during the postoperative appointment on POD 5, approximately 2-4 weeks. |
| Heart Rate | Heart rate will be measured twice during the study, once at the time of consultation and a second time immediately prior to surgery. Heart rate will be recorded in beats per minute (bpm) and summarized by study arm using basic descriptive statistics. | During consultation and again immediately preoperatively on the day of surgery, approximately 2-4 weeks total |
| Mean Arterial Pressure (MAP) | Mean arterial pressure will be measured twice during the study, once at the time of consultation and a second time immediately prior to surgery. MAP will be recorded in millimeters of mercury (mmHg) and summarized by study arm using basic descriptive statistics. | During consultation and again immediately preoperatively on the day of surgery, approximately 2-4 weeks total |
| Background | Nasr, D. A., & Abdellatif, A. A. (2014). Efficacy of preoperative melatonin versus pregabalin on perioperative anxiety and postoperative pain in gynecological surgeries. Egyptian Journal of Anaesthesia, 30(1), 89-93. doi:10.1016/j.egja.2013.10.001 |
| 24835540 | Background | Andersen LP, Werner MU, Rosenberg J, Gogenur I. A systematic review of peri-operative melatonin. Anaesthesia. 2014 Oct;69(10):1163-71. doi: 10.1111/anae.12717. Epub 2014 May 19. |
| 29104591 | Background | Favero G, Franceschetti L, Bonomini F, Rodella LF, Rezzani R. Melatonin as an Anti-Inflammatory Agent Modulating Inflammasome Activation. Int J Endocrinol. 2017;2017:1835195. doi: 10.1155/2017/1835195. Epub 2017 Oct 1. |
| 19223003 | Background | Ambriz-Tututi M, Rocha-Gonzalez HI, Cruz SL, Granados-Soto V. Melatonin: a hormone that modulates pain. Life Sci. 2009 Apr 10;84(15-16):489-98. doi: 10.1016/j.lfs.2009.01.024. Epub 2009 Feb 15. |
| 31260676 | Background | de Carvalho Nogueira EF, de Oliveira Vasconcelos R, Teixeira Correia SS, Souza Catunda I, Amorim JA, do Egito Cavalcanti Vasconcelos B. Is There a Benefit to the Use of Melatonin in Preoperative Zygomatic Fractures? J Oral Maxillofac Surg. 2019 Oct;77(10):2017.e1-2017.e7. doi: 10.1016/j.joms.2019.05.016. Epub 2019 Jun 4. |
| 8623940 | Background | Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996 Mar;82(3):445-51. doi: 10.1097/00000539-199603000-00002. |
| 28186223 | Background | Myles PS, Myles DB, Galagher W, Boyd D, Chew C, MacDonald N, Dennis A. Measuring acute postoperative pain using the visual analog scale: the minimal clinically important difference and patient acceptable symptom state. Br J Anaesth. 2017 Mar 1;118(3):424-429. doi: 10.1093/bja/aew466. |
| 30321520 | Background | Viswanath A, Oreadi D, Finkelman M, Klein G, Papageorge M. Does Pre-Emptive Administration of Intravenous Ibuprofen (Caldolor) or Intravenous Acetaminophen (Ofirmev) Reduce Postoperative Pain and Subsequent Narcotic Consumption After Third Molar Surgery? J Oral Maxillofac Surg. 2019 Feb;77(2):262-270. doi: 10.1016/j.joms.2018.09.010. Epub 2018 Sep 20. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |