Pain, PostoperativePhase 2NCT04791943
Preoperative Melatonin to Decrease Analgesia Usage After Third Molar Surgery
A Phase 2 study testing Melatonin 10 MG and Lactose pill in people with Pain, Postoperative and Narcotic Use, run by Montefiore Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Narcotic Use
- What is being tested?
- Melatonin 10 MG and Lactose pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2021to 20 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- Chronic pain
- Language/communication barrier
- Psychiatric disease/ Mental impairment
- Current or past use of psychotropic drugs
- Pregnancy
- Renal or hepatic impairment
- BMI >35
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center Department of Dentistry
The Bronx, New York, 10467
About this study
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
- Being tested
- Melatonin 10 MG, Lactose pill
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 10 MGDrug
3 melatonin 10mg capsules will be given to the treatment arm
Lactose pillDrug
3 lactose pills will be provided to the control arm
| Study group | Role | What they receive |
|---|---|---|
| Experimental Treatment - Melatonin | Experimental | Premedication for three nights with 10mg melatonin Receives: Drug: Melatonin 10 MG |
| Control Treatment - Lactose | Placebo comparator | Premedication for three nights with lactose capsules Receives: Drug: Lactose pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During consultation and again immediately preoperatively on the day of surgery, approximately 2-4 weeks total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start16 Nov 2021
- Primary completion1 Oct 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Quest Diagnostics-Nichols Insitute, Eurofins Viracor
- Responsible party
- Sponsor
- Investigators
- Jason Baker, DMD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791943
- Sponsor's protocol ID
- 2020-12127
- Status last verified
- Jan 2026
- First submitted
- 2 Mar 2021
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
Publications
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.
PubMed 23410617Cicero 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.
PubMed 24871348Nasr, 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
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.
PubMed 24835540Favero 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.
PubMed 29104591Ambriz-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.
PubMed 19223003de 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.
PubMed 31260676Moerman 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.
PubMed 8623940Myles 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.
PubMed 28186223Viswanath 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.
PubMed 30321520
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Melatonin to Decrease Analgesia Usage After Third Molar Surgery
- ClinicalTrials.gov ID
- NCT04791943
- Acronym / sponsor ID
- 2020-12127
- Conditions
- Pain, Postoperative, Narcotic Use
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Quest Diagnostics-Nichols Insitute, Eurofins Viracor
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Treatment - Melatonin | Experimental | Drug: Melatonin 10 MGPremedication for three nights with 10mg melatonin |
| Control Treatment - Lactose | Placebo comparator | Drug: Lactose pillPremedication for three nights with lactose capsules |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin 10 MG3 melatonin 10mg capsules will be given to the treatment arm | Drug | Experimental Treatment - Melatonin |
| Lactose pill3 lactose pills will be provided to the control arm | Drug | Control Treatment - Lactose |
Primary outcome
Postoperative narcotic consumption
Time frame: From the time of intervention to the completion of the surveys, approximately 2-4 weeks total
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.
7 secondary outcomes
Inflammatory cytokine markers - IL-6, IL-8, TNF-alpha concentrations
Time frame: Blood draws during consultation, immediately prior to surgery, and at POD5, approximately 2-4 weeks total
Inflammatory markers - CRP concentrations
Time frame: Blood draws during consultation, immediately prior to surgery, and at POD5, approximately 2-4 weeks total
Preoperative Anxiety
Time frame: On the day of surgery prior to the procedure, approximately 2-4 weeks after enrollment
Preoperative Sleep Quality
Time frame: On the day of surgery prior to the procedure, approximately 2-4 weeks after enrollment
Post operative pain
Time frame: 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
Time frame: During consultation and again immediately preoperatively on the day of surgery, approximately 2-4 weeks total
Mean Arterial Pressure (MAP)
Time frame: During consultation and again immediately preoperatively on the day of surgery, approximately 2-4 weeks total
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Background: PubMed 23410617Jones 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.
- Background: PubMed 24871348Cicero 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.
- BackgroundNasr, 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: PubMed 24835540Andersen 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.
- Background: PubMed 29104591Favero 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.
- Background: PubMed 19223003Ambriz-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.
- Background: PubMed 31260676de 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.
- Background: PubMed 8623940Moerman 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.
- Background: PubMed 28186223Myles 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.
- Background: PubMed 30321520Viswanath 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.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Baker, DMD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Melatonin 10 MG and Lactose pill in people with Pain, Postoperative and Narcotic Use, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative narcotic consumption (time frame: From the time of intervention to the completion of the surveys, approximately 2-4 weeks total). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04791943, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.