Effect of Preoperative Diclofenac Potassium on Postoperative Endodontic Pain

Cairo University (CU) logo

Cairo University (CU)

Status and phase

Completed
Phase 3
Phase 2

Conditions

Pulpitis - Irreversible

Treatments

Drug: Diclofenac Potassium 50mg Tab.
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03341260
CEBC-CU-2016-11-167

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 on postoperative endodontic pain in mandibular molars with symptomatic irreversible pulpitis.

Full description

Patients with moderate-to-severe preoperative pain are selected. Patients receive either a single-dose of 50 mg diclofenac potassium (group A) or a placebo tablet as a control (group B). All patients receive the assigned premedication one hour before single-visit root canal treatment. Postoperative endodontic pain is measured at the following time points: 6 , 12,24,48 h after treatment. The incidence of analgesic intake is also recorded.

Enrollment

70 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with active pain (moderate-to-severe) in mandibular molars.
  • Patients with prolonged response to cold testing and electric pulp tester.
  • Patient with the ability to understand and use pain scales.
  • Patient with vital coronal pulp tissue on access.
  • Patient who accept to enroll to the study.

Exclusion criteria

  • Patients' allergies or any other contraindication to diclofenac potassium or articaine.
  • Pregnant and lactating females.
  • Patients having pain medication in the last 6 hours.
  • Patient has more than one symptomatic mandibular tooth in the same quadrant.
  • Patients with periradicular pathosis and/or radiolucency other than widened periodontal ligaments.
  • Patients with active peptic ulcer and gastrointestinal disorders.
  • Patients with history of bleeding problems or anticoagulant use within the last month.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

70 participants in 2 patient groups, including a placebo group

Diclofenac Potassium 50mg tab
Experimental group
Description:
Diclofenac Potassium 50mg tablet to be administered one hour before treatment.
Treatment:
Drug: Diclofenac Potassium 50mg Tab.
Placebo
Placebo Comparator group
Description:
Placebo to be administered one hour before treatment.
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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