Skip to content

Use of Melatonin in the control of pain in face fractures

Use of melatonin as an analgesic adjuvant in face fractures

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-878g2j
Enrollment
Unknown
Registered
2019-08-26
Start date
2017-01-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety disorder, unspecified

Interventions

A double-blind, randomized study was conducted, and the sample consisted of 72 patients hospitalized at the Restoration Hospital with zygomatic bone fracture and indication of surgical treatment under
Drug
E04.545

Sponsors

Universidade de Pernambuco
Lead Sponsor
Universidade de Pernambuco
Collaborator
Hospital da Restauração
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients between 18 and 60 years of ag; ASA I and II; who had a unilateral fracture of the zygomatic bone; with a trauma time of less than 15 days; and who showed indication of surgical treatment with at least 2 access points and fixation.

Exclusion criteria

Exclusion criteria: Patients who do not fit the planning of surgical and anesthetic techniques; have fractures in other regions; need coronal access; use other medications in the postoperative period; or present allergy to study medications will be excluded.

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: It is expected to improve the operative pain of patients who use melatonin through the use of transoperative opioids when compared to placebo, from the finding of a variation of at least 5% between groups.;Result Found 1: Patients using melatonin required less opioids compared to placebo (0.296 more or less 0.036 mcg/kg/ min vs. 0.372 more ou less 0.037 mcg/kg /min), with statistical difference from finding a variation of at minus 5% between groups.

Secondary

MeasureTime frame
Expected outcome 2: It is expected to find an improvement in the sleep quality of the inpatients who use melatonin, evaluated using the Sleep Quality Rating Scale.;Result Found 2: In the sleep quality evaluation of the night before surgery, 61.1% of the patients in the Melatonin group reported better or much better sleep than usual, while 100% of the Placebo group reported worse sleep than or equal to usual (p less than 0.001).

Countries

Brazil

Contacts

Public ContactEmerson Nogueira

Universidade de Pernambuco

emerson_filipe@hotmail.com+55 (81) 3183-3674

Outcome results

None listed

Source: REBEC (via WHO ICTRP)