Preoperative Melatonin to Decrease Analgesia Usage After Third Molar Surgery

Pain, Postoperative Clinical Trial

Official title:

Preoperative Melatonin to Decrease Analgesia Usage After Third Molar Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04791943
• Other study ID #: 2020-12127
• Status: Recruiting
• Phase: Phase 2
• Start date: May 12, 2021
• Est. completion date: April 2024

Study information

• Verified date: January 2024
• Source: Montefiore Medical Center
• Contact: Charles K Levin, DDS
• Phone: 718-904-8190
• Email: montefioreomfs[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Narcotic Use
• Pain, Postoperative

Intervention

Drug:
• Melatonin 10 MG
3 melatonin 10mg capsules will be given to the treatment arm
• Lactose pill
3 lactose pills will be provided to the control arm

Locations

Country	Name	City	State
United States	Montefiore Medical Center Department of Dentistry	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative narcotic consumption	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.	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	Inflammatory markers	The investigators will measure blood levels of IL6, IL8, TNF-alpha, and CRP to try and estimate the systemic inflammatory response.	Blood draws at the consultation, surgery day, and at the 5 day post operative visit (~2-4 week window).
Secondary	Preoperative Anxiety	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).	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.
Secondary	Post operative pain	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.	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.
Secondary	Heart Rate	The heart rate will be measured at the consultation and surgery appointment for comparison between groups.	Heart rate will be measured two times, once at the consultation and again at the surgery appointment 2-4 weeks later.
Secondary	Blood Pressure	The mean arterial pressure (MAP) will be measured at the consultation and surgery appointment for comparison between groups.	MAP will be measured two times, once at the consultation and again at the surgery appointment 2-4 weeks later.

External Links

•   2. Centers for Disease Control and Prevention. (2014). Opioid Painkiller Prescribing, Where You Live Makes a Difference. Atlanta, GA: Centers for Disease Control and Prevention.
•   General information on opioid abuse, What are Opioids?, U.S. Department of Health and Human Services