The Effect of Melatonin on Postoperative Pain Reduction After Orthognathic Surgery

• Status: Recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The University of Hong Kong
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Melatonin; Sodium sulfate

Criteria

Inclusion Criteria:

• ASA Class I

• Age between 18 - 60 inclusive

Exclusion Criteria:

• 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