Ketorolac Premedication for Anesthetic Efficiency of IANB & Postendodontic Pain in Teeth With Irreversible Pulpitis

Effect of Ketorolac Premedication on Anesthetic Efficiency of Inferior Alveolar Nerve Block, Pre-Treatment and Post-Endodontic Pain in Teeth With Irreversible Pulpitis: A Randomized Controlled Double Blinded Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02940405

Enrollment

Registered

2016-10-20

Start date

2017-01-31

Completion date

2018-01-31

Last updated

2016-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irreversible Pulpitis

Keywords

Post-operative pain, Irreversible Pulpitis, Oral premedication, Ketorolac Premedication, Anesthetic Efficiency, Post-Endodontic Pain

Brief summary

The aim of this study to assess effect of ketorolac premedication on the effectiveness of the inferior alveolar nerve block, pretreatment and postoperative pain in patients with symptomatic irreversible pulpitis.

Detailed description

* Patients will be clinically and radiographically examined and their eligibility will be assessed and preoperative pain will be measured. Eligible patients will be treated in one visit. * Patients will be randomly assigned to one of 2 groups: experimental group (taking a 10 mg tablet of ketorolac) and the control group (taking a placebo tablet). Each tablet will be taken one hour before starting treatment. The patient's pain will be assessed before local anesthetic adminstration. After 15 minutes of the initial inferior alveolar nerve block (IANB), the teeth will be examined using a cold pulp sensitivity test; in case of no or mild pain, the treatment will be initiated. * During root canal treatment, no to mild pain response will be considered success. In case of failure, supplemental anesthesia will be administrated. * Postoperative pain will be assessed 6, 12, 24 and 48 hours after treatment. The number of patients who will require rescue analgesic medication within the 48 hours postoperatively will be counted.

Interventions

DRUGKetorolac Tromethamine

A 10 mg tablet of the medication will be given one hour before starting the root canal treatment

DRUGPlacebo

The placebo given as a tablet one hour before staring the root canal treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

1. Age between 18-45 years old. 2. Males or Females. 3. Mandibular Posterior teeth with symptomatic irreversible pulpitis. 4. Patients with non-contributory systemic condition.

Exclusion criteria

1. Patients allergic to any analgesics or antibiotics or anesthetics 2. Pregnant females 3. If analgesics have been administrated during the past 8 hours before endodontic treatment. 4. Irrestorable teeth.

Design outcomes

Primary

Measure	Time frame	Description
Anesthetic efficiency	Intraoperative (During endodontic treatment)	Pain during endodontic treatment will be assessed using a numerical rating scale (NRS). No or mild pain response will be considered success.

Secondary

Measure	Time frame	Description
Postoperative pain	At 6,12, 24, 48 hours after root canal treatment	Postoperative pain will be measured using a numerical rating scale (NRS)
Number of patients requiring rescue analgesic.	Within 48 hours after endodontic treatment	Number of patients requiring rescue analgesic within 48 hours after endodontic treatment

Contacts

Primary ContactLaila Z Ismail, Postgraduate

Laila.zakaria@dentistry.cu.edu.eg+002 (01223487628)

Backup ContactSuzan AW Amin, PhD

swanees@rockmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026