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Comparative study of Dexamethasone associated with Nimesulide and Dexamethasone plus Paracetamol in control of Pain, Swelling and postoperative Oral Opening Difficulty

Comparative study between Dexamethasone co-administered with Nimesulide and Dexamethasone co-administered with Paracetamol in postoperative Pain control, Edema and Trismus

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-96g5cq
Enrollment
Unknown
Registered
2020-01-20
Start date
2017-06-20
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

Pain

Interventions

Two surgeries on different occasions under local anesthesia in twenty patients. Where an hour before will be given Dexamethasone 8mg plus nimesulide 100mg in one surgery and dexamethasone 8mg plus par
Drug
Procedure/surgery
Q65.070

Sponsors

Universidade do Estado do Rio Grande do Norte
Lead Sponsor
Universidade do Estado do Rio Grande do Norte
Collaborator

Eligibility

Age
18 Years to 45 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Brazil

Contacts

Public ContactErasmo Souza Junior

Universidade do Estado do Rio Grande do Norte

erasmo_jn@hotmail.com+55(84) 3315-2248

Outcome results

None listed

Source: REBEC (via WHO ICTRP)