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To check the efficacy of inferior alveolar nerve block in patients with symptomatic irreversible pulpitis after premedication with ketorolac and diclofenac potassium

Effect of prophylactically administered ketorolac and diclofenac potassium on the efficacy of inferior alveolar nerve block in patients with symptomatic irreversible pulpitis.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000633785
Enrollment
130
Registered
2022-04-28
Start date
2022-05-02
Completion date
2022-12-14
Last updated
2023-09-26

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

Conditions

None listed

Brief summary

The primary purpose of this study is to compare prophylactic ketorolac and diclofenac potassium on the efficacy of inferior alveolar nerve block in patients presenting with symptomatic irreversible pulpitis. The null hypothesis stating that "there is no difference in peri-operative pain during endodontic treatment in patients taking prophylactic Ketorolac and Diclofenac Potassium" will be tested in this trial.

Interventions

The effect of premedication with single dose of tablet Ketorolac (10mg) given orally, 1 hour prior to initiation of root canal treatment, on the efficacy of Inferior alveolar nerve block (IANB) in patients presenting with symptomatic irreversible pulpitis. The drug will be given to the patient to be taken by oral route under supervision of principal investigator and mouth check will be done to check adherence to the intervention. 1 hour after premedication with the drug, nerve block will be adm

The effect of premedication with single dose of tablet Ketorolac (10mg) given orally, 1 hour prior to initiation of root canal treatment, on the efficacy of Inferior alveolar nerve block (IANB) in patients presenting with symptomatic irreversible pulpitis. The drug will be given to the patient to be taken by oral route under supervision of principal investigator and mouth check will be done to check adherence to the intervention. 1 hour after premedication with the drug, nerve block will be administered by the principal investigator and patient will be asked about feeling of lip numbness to confirm the onset of anesthesia, 15 mins after administration of nerve block. The drug used for IANB will be 1.8 mL of 2% lidocaine containing 1: 200 000 epinephrine (Septodont). The effect of nerve block will be cross checked with cold test using Ethyl chloride spray. If cold test shows negative response then root canal procedure will be initiated after rubber dam isolation. The approximate duration of root canal procedure will be 45 minutes.

Sponsors

Dr. Sara Bano
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

Healthy adult patients Age 18 - 60 years First and second mandibular molars with history of Symptomatic Irreversible Pulpitis Moderate or severe pain score on Visual Analogue Scale No premedication with any drug 12 hours prior to treatment

Exclusion criteria

Any known allergy to NSAID medication or lignocaine Pregnant females Lactating females Those who will not be able to give informed consent Patients with active peptic ulcers Teeth declared necrotic upon investigation with cold test using ethyl chloride Patients only experiencing mild pain (0-3) on Visual Analogue Scale

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026