Efficacy of Preoperative Diclofenac Potassium- Acetaminophen Combination on Anesthetic Success in Patients With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial

Cairo University (CU)

Status: Unknown

Conditions: Symptomatic Irreversible Pulpitis

Treatments: Drug: Diclofenac potassium- acetaminophen combination; Drug: Placebo; Drug: Diclofenac potassium

Study type: Interventional

Funder types: Other

Identifiers

NCT04593160

CU-ENDO-6-10-2020.

Details and patient eligibility

About

The purpose of this study is to assess the effect of preoperative a single-dose of 50 mg diclofenac potassium- 1000mg acetaminophen combination compared to diclofenac potassium alone or placebo on local anesthetic success and postoperative pain in patients with symptomatic irreversible pulpitis.

Full description

Patients with moderate-to-severe preoperative pain are selected. Patients receive either a single-dose of diclofenac potassium (50mg)- acetaminophen (1000mg) combination, diclofenac potassium (50mg) alone or a placebo tablet as a control. All patients will receive the assigned premedication one hour before single-visit root canal treatment. Anesthetic success of inferior alveolar nerve block will be assessed during access and instrumentation. Postoperative endodontic pain is measured at the following time points: 6,12,24,48,72h and 7 days after treatment.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with symptomatic irreversible pulpitis with/without mechanical allodynia
• Patients with moderato to severe spontaneous pain
• Mandibular molars
• Patients with the ability to understand and use the pain scale
• Patients accepting enrollment in the study

Exclusion criteria

• Patients allergic to any medication or material to be used in the study
• Pregnant and lactating females
• Patients taking medications affecting pain perception in the last 12 hours
• Patients having more than one symptomatic molar in the same quadrant
• Patients with contributory medical history (ASA > II)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 3 patient groups, including a placebo group

Diclofenac potassium- acetaminophen combination

Experimental group

Description:

Preoperative single dose of diclofenac potassium(50mg)- acetaminophen(1000mg) combination

Treatment:

Drug: Diclofenac potassium- acetaminophen combination

Diclofenac potassium

Experimental group

Description:

Preoperative single dose of diclofenac potassium(50mg)

Treatment:

Drug: Diclofenac potassium

Placebo

Placebo Comparator group

Description:

Preoperative single dose of placebo

Treatment:

Drug: Placebo