Multimodal Preemptive Analgesia in third molar surgery, a randomized clinical trial

Evaluation of the efficacy of Multimodal Preemptive Analgesia with Nimesulide and Tramadol Hydrochloride versus Dexamethasone in controlling pain, edema and trismus after extraction of lower third molars

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-8dyvkz7

Enrollment

Unknown

Registered

2025-07-25

Start date

2025-08-01

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

Molar, Third

Interventions

This is a randomized, controlled, two-arm, split-mouth, triple-blind clinical trial. A sample size calculation will be performed through a pilot study with four patients, taking into account all the m

V03.175.250.500

E06.892

E02.319.703

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients over 18 years of age; both sexes; without general health impairment according to medical history and physical examination; patients with indication for extraction of bilateral mandibular third molars; impacted; asymptomatic; in class IIB position, according to the Pell & Gregory classification; with similar surgical difficulty

Exclusion criteria

Exclusion criteria: Patients with a history of hypersensitivity to any of the components of the medications used; patients who have used anti-inflammatory drugs in the 15 days prior to surgery; patients with tuberculosis, leukocytosis, collagen vascular diseases, multiple sclerosis, HIV infection, and other autoimmune diseases; pregnant and lactating patients; patients with a history of pericoronitis; patients with cognitive disorders that make it impossible to understand and execute commands; patients who withdraw consent

Design outcomes

Primary

Measure	Time frame
To evaluate the effectiveness of using Tramadol Hydrochloride associated with Nimesulide in controlling pain, edema and trismus after extraction of mandibular third molars.	—

Secondary

Measure	Time frame
To compare the clinical efficacy between multimodal therapy using Tramadol Hydrochloride + Nimesulide vs. Dexamethasone in the postoperative control of patients undergoing extraction of mandibular third molars;To assess the anxiety and quality of life of patients undergoing extraction of the lower third molar with each of the medications.	—

Countries

Brazil

Contacts

Public ContactRafael Santiago de Almeida

Universidade Federal dos Vales do Jequitinhonha e Mucuri - UFVJM

rafaelsantiago@outlook.com+55(38)99113-9600

Outcome results

None listed

Source: REBEC (via WHO ICTRP)