Clinical Trial Details
— Status: Suspended
Administrative data
| NCT number |
NCT03995004 |
| Other study ID # |
UW 19-221 |
| Secondary ID |
|
| Status |
Suspended |
| Phase |
Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
October 2022 |
| Est. completion date |
September 2024 |
Study information
| Verified date |
October 2021 |
| Source |
The University of Hong Kong |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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.
The normal physiological roles of melatonin in the human body are to regulate diurnal rhythm,
sleep, mood, immunity, reproduction, intestinal motility, and metabolism. Oral supplemental
melatonin has been used in the management of jetlag and other sleep disorders. Recently,
melatonin's analgesic, antioxidative, and neuroprotective properties have been highlighted in
a number of animal models and a few human trials, although the exact cellular mechanism is
still not yet clearly established. In surgical human trials, some conflicting data have been
presented regarding the analgesic properties of exogenous melatonin supplement. Whilst the
large proportion of studies showed that perioperative administration of melatonin yielded
significantly positive effects in the reduction of postsurgical pain, and the reduction of
overall morphine consumption, others demonstrated the opposite with no significant effects in
pain experience. The reason for this could be related to the dosage, route of administration,
and/or time of administration. To date, there is still no consensus on a standardized dosing
regimen for melatonin. In non-surgical trials, melatonin has shown promising benefits in many
degenerative diseases and conditions related to chronic inflammation and oxidative stress.
Amongst many, the reported positive effects of melatonin ranged from the reduction of
radiation dermatitis, control of signs and symptoms of ulcerative colitis, management of
chronic retinopathy, and reduction of lung oxidative stress in chronic obstructive pulmonary
disease patients.
Hypothesis:
Melatonin can significantly reduce postoperative pain after orthognathic surgery.
Antioxidative enzyme activity and level will be elevated and the level of inflammatory
markers are reduced. Melatonin has a synergistic effect with dexamethasone.
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.
