Clinical trial NCT04593160: Efficacy of Preoperative Diclofenac Potassium- Acetaminophen Combination on Anesthetic Success in Patients With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial
Official title: Efficacy of Preoperative Diclofenac Potassium- Acetaminophen Combination on Anesthetic Success in Patients With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Symptomatic Irreversible Pulpitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Anesthetic success of inferior alveolar nerve block
timeFrame: During the treatment
Secondary outcomes:
measure: Postoperative pain at 6 hours
timeFrame: 6 hours
measure: Postoperative pain at 12 hours
timeFrame: 12 hours
measure: Postoperative pain at 24 hours
timeFrame: 24 hours
measure: Postoperative pain at 48 hours
timeFrame: 48 hours
measure: Postoperative pain at 72 hours
timeFrame: 72 hours
measure: Postoperative pain at 7 days
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
References:
citation: Nagendrababu V, Pulikkotil SJ, Veettil SK, Teerawattanapong N, Setzer FC. Effect of Nonsteroidal Anti-inflammatory Drug as an Oral Premedication on the Anesthetic Success of Inferior Alveolar Nerve Block in Treatment of Irreversible Pulpitis: A Systematic Review with Meta-analysis and Trial Sequential Analysis. J Endod. 2018 Jun;44(6):914-922.e2. doi: 10.1016/j.joen.2018.02.017. Epub 2018 Apr 27.
citation: Ianiro SR, Jeansonne BG, McNeal SF, Eleazer PD. The effect of preoperative acetaminophen or a combination of acetaminophen and Ibuprofen on the success of inferior alveolar nerve block for teeth with irreversible pulpitis. J Endod. 2007 Jan;33(1):11-4. doi: 10.1016/j.joen.2006.09.005.
citation: Al-Rawhani AH, Gawdat SI, Wanees Amin SA. Effect of Diclofenac Potassium Premedication on Postendodontic Pain in Mandibular Molars with Symptomatic Irreversible Pulpitis: A Randomized Placebo-Controlled Double-Blind Trial. J Endod. 2020 Aug;46(8):1023-1031. doi: 10.1016/j.joen.2020.05.008. Epub 2020 May 26.