A comparison of the effectiveness of additional injections of opioid and anaesthetic in emergency root canal treatment of adult lower teeth

A comparison of the effectiveness of supplementary intraligamentary injections of tramadol and lignocaine in emergency root canal treatment of adult mandibular molars with irreversible pulpitis: a randomized control trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/05/018900

Enrollment

Registered

2019-05-02

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: K040- Pulpitis

Interventions

Intervention1: intraligamentary tramadol injection: 60 mg (1.2 ml) tramadol injection is given intraligamentary (route of administration) once to the patients in which inferior alveolar nerve block f

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy adults (ASA-I or ASA-II), aged between 18 â?? 65 years, who signed consent form. 2. Symptomatic irreversible pulpitis of the mandibular first or second molar. a) The patients who have pain in a mandibular molar (visual analog scale >54) with prolonged response to cold testing (lingering pain for more than 45 seconds). b) Absence of any periapical radiolucency on a periapical radiograph (except for a widened periodontal ligament of no more than 0.75â??1 mm and no pain on percussion). 3. Vital teeth with no history of previous root canal therapy. 4. Ability to understand the consent forms and the pain record scales.

Exclusion criteria

Exclusion criteria: 1. A known allergy, sensitivity, or contraindications to any local anaesthetics or opioids. Those patients who show any abnormal reaction to the test dose of the drugs. 2. History of seizures, systemic diseases such as diabetes, uncontrolled hypertension, acute or severe bronchial asthma, significant respiratory depression, decreased renal or liver function. 3. Pregnancy or lactation. 4. History of narcotics or psychotic drugs, patients who had taken NSAIDs or sedatives within 24 hours before the root canal treatment. 5. Patients experiencing pain in more than 1 mandibular molar. 6. During the procedure, patients will be excluded if lip numbness is not achieved after the inferior alveolar nerve block.

Design outcomes

Primary

Measure	Time frame
Modified Heft Parker Visual Analog Scale pain scoreTimepoint: 1) Pre-operative pain score 2) Intra-operative pain score 3) Post-operative pain score after 6 hours 4) Post-operative pain after 12 hours	—

Secondary

Measure	Time frame
Heart rateTimepoint: Intra-operative	—

Countries

India

Contacts

Public ContactDr Aviraj Damrekar

Dr. G. D. Pol Foundation Y.M.T. Dental, College and Hospital

USHAINA@GMAIL.COM9867052493

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026