The Effect of Melatonin on Postoperative Pain Reduction After Orthognathic Surgery

NCT03995004 | Suspended Phase 1 FDA Drug

• 1 other identifier: UW 19-221
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

Orthognathic surgery is a procedure performed to correct dentofacial deformities. It involves osteotomy at the facial skeleton. Considerable pain is expected in the early recovery period. Melatonin is a hormone that is produced naturally by the body. Synthetic Melatonin is available over the counter for the management of sleeping disorder and jetlag. Clinically, Melatonin can also be used to reduce pain and analgesic consumption in patients undergoing surgery. Dexamethasone is a type of steroid. It can suppress the inflammatory response. It is an anti-inflammatory, anti-allergic drug. It is commonly used in head and neck and oral surgery for its anti-inflammatory effect to reduce swelling. This study aims evaluate the efficacy of oral melatonin in the pain reduction following orthognathic surgery. This is a double-blinded randomized controlled trial. We will recruit 87 patients who are scheduled for double-jaw orthognathic surgery to participate in this three-year study. The study lasts for 2 weeks. Participant will be randomly allocated by computer to one of the three groups. (1) Group D will receive dexamethasone only; (2) Group M will receive melatonin only; and (3) Group DM both melatonin and dexamethasone. Postoperative pain level and perioperative plasma levels of inflammatory markers and anti-oxidizing enzymes will be recorded and compared among the study groups.

Conditions

Effect of Drugs

Keywords

melatonin; orthognathic; pain; surgery

Outcome Measures

Primary Outcomes (2)

• Subjective pain perception

  Self-reported pain level by numerical rating scale

  14 days

• Total analgesic consumption

  Total amount of postoperative analgesic consumed

  14 days

Secondary Outcomes (5)

• Time to first analgesic

  1 day

• Plasma levels of melatonin

  16 days

• Plasma levels of inflammatory markers

  16 days

• Plasma levels of hydrogen peroxide

  16 days

• Plasma levels and activities of antioxidative enzymes

  16 days

Study Arms (3)

Melatonin

EXPERIMENTAL

Oral Melatonin 10mg at night time one day before the surgery and on the surgical day, and continued at bedtime on the surgical day, post-surgery day 1 and day 2. IV Normal Saline (1mL) on induction and continued q12h for 4 more doses.

Drug: Melatonin

Dexamethasone

ACTIVE COMPARATOR

Placebo capsules at night time one day before the surgery and on the surgical day, and continued at bedtime on the surgical day, post-surgery day 1 and day 2. IV Dexamethasone 4mg/1mL on induction and continued q12h for 4 more doses

Drug: Dexamethasone Sodium Sulphate 4mg/1mL

Dexa_Melatonin

EXPERIMENTAL

Oral Melatonin 10mg at night time one day before the surgery and on the surgical day, and continued at bedtime on the surgical day, post-surgery day 1 and day 2. IV Dexamethasone 4mg/1mL on induction and continued q12h for 4 more doses

Drug: Melatonin; Drug: Dexamethasone Sodium Sulphate 4mg/1mL

Interventions

Melatonin DRUG

Melatonin (N-acetyl-5-methoxytryptamine) is a neurohormone that is endogenously produced and secreted by the pineal gland in the brain following a circadian rhythm, with a plasma concentration highest at night and lowest during the day.

Dexa_Melatonin; Melatonin

Dexamethasone Sodium Sulphate 4mg/1mL DRUG

Dexamethasone is a glucocorticoid commonly used in orthognathic surgery to reduce postoperative facial edema by its potent anti-inflammatory effect

Also known as: Decadron

Dexa_Melatonin; Dexamethasone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA Class I
• Age between 18 - 60 inclusive

You may not qualify if:

• Pregnancy
• Any pre-existing systemic condition
• Previous history of orthognathic surgery
• Adverse reaction or allergic to oral melatonin
• Need for distraction osteogenesis
• Patient with chronic pain
• Patients with known psychological disorders
• Currently taking oral steroid or anti-inflammatory medication or any analgesic

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Prince Philip Dental Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Pain

Interventions

Melatonin; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, 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; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Winnie WS CHOI, PhD, MDS

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Identical capsules for melatonin and placebo Clear fluid of the same volume for IV dexamethasone vs normal saline
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: M: Oral Melatonin 10mg / IV Normal Saline D: Placebo cap / IV Dexamethasone 4mg DM: Oral Melatonin 10mg / IV Dexamethasone 4mg

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 21, 2019
• Study Start: October 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: June 3, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)