Preoperative Melatonin to Decrease Analgesia Usage After Third Molar Surgery

NCT04791943 | Completed Phase 2 DMC

• 1 other identifier: 2020-12127
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Narcotic Use

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Inflammatory cytokine markers - IL-6, IL-8, TNF-alpha concentrations

  Blood draws during consultation, immediately prior to surgery, and at POD5, approximately 2-4 weeks total

• Inflammatory markers - CRP concentrations

  Blood draws during consultation, immediately prior to surgery, and at POD5, approximately 2-4 weeks total

• Preoperative Anxiety

  On the day of surgery prior to the procedure, approximately 2-4 weeks after enrollment

• Preoperative Sleep Quality

  On the day of surgery prior to the procedure, approximately 2-4 weeks after enrollment

• Post operative pain

  The morning of the first 3 postoperative days (approximately 72 hours postoperatively) and during the postoperative appointment on POD 5, approximately 2-4 weeks.

Study Arms (2)

Experimental Treatment - Melatonin

EXPERIMENTAL

Premedication for three nights with 10mg melatonin

Drug: Melatonin 10 MG

Control Treatment - Lactose

PLACEBO COMPARATOR

Premedication for three nights with lactose capsules

Drug: Lactose pill

Interventions

Melatonin 10 MG DRUG

3 melatonin 10mg capsules will be given to the treatment arm

Experimental Treatment - Melatonin

Lactose pill DRUG

3 lactose pills will be provided to the control arm

Control Treatment - Lactose

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject must have 3-4 partial or full bony impacted third molars requiring surgical extraction under IV sedation
• Ages 18-35
• American Society of Anesthesiologists (ASA) Class I or II
• English or Spanish speaking patients
• Capacity to sign informed consent

You may not qualify if:

• Allergies to melatonin, opioids, or other Over-the-counter (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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Quest Diagnostics-Nichols Insitute: collaborator
• Eurofins Viracor: collaborator

Study Sites (1)

Montefiore Medical Center Department of Dentistry

The Bronx, New York, 10467, United States

Location

Related Publications (10)

• 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.

  PMID: 23410617 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.

  PMID: 24871348 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

  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.

  PMID: 24835540 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.

  PMID: 29104591 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.

  PMID: 19223003 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.

  PMID: 31260676 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.

  PMID: 8623940 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.

  PMID: 28186223 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.

  PMID: 30321520 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Melatonin; Lactose

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Jason Baker, DMD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The surgeon and the patient will be masked, the research coordinator will not be masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 10, 2021
• Study Start: November 16, 2021
• Primary Completion: October 1, 2025
• Study Completion: October 20, 2025
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)