Comparative study of Dexamethasone associated withNimesulide and Dexamethasone plus Paracetamol incontrol of Pain, Swelling and postoperative Oral Opening Difficulty

Phase 2

• Conditions: Pain; edema; trismus; C23.888.592.612; C23.888.277; C10.597.613.750.700

• Registration Number: RBR-96g5cq
• Lead Sponsor: niversidade do Estado do Rio Grande do Norte

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-20
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Voluntary patients, coming from spontaneous demand from the Unified Health System (SUS), attended at the dependencies of the UERN Dentistry Course;
Between 16 and 45 years old;
Agree to participate in research after reading the Informed Consent Form (ICF);
Classified according to the American Society of Anesthesiology (ASA), in group I (normal healthy, with no systemic changes or continuous use of medications);
With indication of lower third molar extraction, bilaterally. These, necessarily, with the same degree of inclusion as compared to their contralateral, following the classifications of Pell and Gregory and Winter.

Exclusion Criteria

Report having had unpleasant previous experiences (reactions or allergic processes) to any of the drugs used in this research;
Use concomitant medication (except for oral contraceptives);
Do not fit into the planning of surgical and anesthetic techniques;
Not returning for the second surgery, (surgery on the opposite side);
Do not return to the assessments;
Inability to answer the questionnaires;
Do not correctly fill in the evaluation forms.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The following primary parameters of use were: pain (by Visual Analogue Scale - EVA, total number of rescue analogs consumed and time required to consume the first rescue analog), edema and trismus. For this, statistical tests were performed, where the significance level of 5% was adopted. After analysis of the Kolmogorov-Smirnov normality, as means that obtain normal patterns between groups for each studied variable, they were compared using the paired t-test. Media with abnormal pattern were compared by Wilcoxon test. Values of p less than 0.05 were considered statistically significant. Overall, the best results were not found in the Dexamethasone 8mg plus Nimesulide 100mg group in the pain and trismus variables, but the differences for these variables were not statistically significant. However, the association of the group Dexamethasone 8mg plus Paracetamol 1g presents the best results in relation to postoperative edema, presenting a statistically significant difference at 48h.

Secondary Outcome Measures

Name	Time	Method
The following secondary endpoint evaluated was patient satisfaction. For this, statistical tests were performed, where the significance level of 5% was adopted. After analysis of Kolmogorov-Smirnov normality, the means that showed abnormality patterns were thus compared using the Wilcoxon test. A value of p” less than 0.05 was considered statistically significant. Overall, better results were found in the Dexamethasone 8mg plus Nimesulide 100mg group, but were not statistically significant.