comparison of efficacy of tramadol hydrochloride versus linocaine hydrochloride as Local anesthetic and analgesic agent A single blind split mouth study.

A COMPARISON OF THE EFFICACY OF TRAMADOL HYDROCHLORIDE VERSUS LIGNOCAINE HYDROCHLORIDE AS LOCAL ANAESTHETIC AND ANALGESIC AGENT FOR ORTHODONTIC EXTRACTION OF MAXILLARY PREMOLAR A SINGLE BLIND SPLIT MOUTH STUDY. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/069607

Enrollment

Registered

2024-06-27

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-22

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

Conditions

Health Condition 1: K088- Other specified disorders of teethand supporting structures

Interventions

Intervention1: Inj.TRAMADOL HYDROCHLORIDE: 1.0 ml of 50 mg of tramadol hydrochloride will be given orally as Buccal mucosa and palatal Mucosa infiltration for tooth to be extracted using 27 gauge need

Eligibility

Inclusion criteria

Inclusion criteria: 1.Healthy Patients within age group 12 to 40 years. 2.Patients classified under ASA I. 3.Patients who are willing to participate in the study by signing the informed consent. 4.Patients indicated for orthodontic extraction of maxillary premolar. 5.Patients who can comprehend the pain scale used in the study.

Exclusion criteria

Exclusion criteria: 1.Patients classified under ASA II, III and IV. 2.Pregnant or lactating women. 3.Patients with previous history of allergy to Local Anaesthetic Agent. 4.Patients with previous history of allergy to tramadol. 5.Patients with pre-existing paresthesia. 6.Patients on antidepressants, anticoagulants, psychotropic drugs. 7.Epileptic Patients. 8.Patients under the Influence of Alcohol. 9.Patients requiring additional Anaesthesia

Design outcomes

Primary

Measure	Time frame
Clinical Parameters: 1. Evaluation of the response (Allergic reaction) 2. Pain on injection 3. Onset of action 4. Peak Effect 5. Total duration of anaesthesia 6. Postoperative Analgesic IntakeTimepoint: Clinical Parameters: 1. Evaluation of the response (Allergic reaction)-15-20 minute 2. Pain on injection-10 seconds 3. Onset of action-every 10 second interval 4. Peak Effect- every 2 minute 5. Total duration of anaesthesia- every 5 minute until to check disappearance of anesthesia 6. Postoperative Analgesic Intake	—

Measure

Time frame

Clinical Parameters: 1. Evaluation of the response (Allergic reaction) 2. Pain on injection 3. Onset of action 4. Peak Effect 5. Total duration of anaesthesia 6. Postoperative Analgesic IntakeTimepoint: Clinical Parameters: 1. Evaluation of the response (Allergic reaction)-15-20 minute 2. Pain on injection-10 seconds 3. Onset of action-every 10 second interval 4. Peak Effect- every 2 minute 5. Total duration of anaesthesia- every 5 minute until to check disappearance of anesthesia 6. Postoperative Analgesic Intake

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Secondary

Measure	Time frame
Clinical Parameters: 1. Evaluation of the response (Allergic reaction) 2. Pain on injection 3. Onset of action 4. Peak Effect 5. Total duration of anaesthesia 6. Postoperative Analgesic IntakeTimepoint: Clinical Parameters: 1. Evaluation of the response (Allergic reaction)-15-20 minute 2. Pain on injection 3. Onset of action-every 10 second interval 4. Peak Effect- 5. Total duration of anaesthesia- every 5 minute until to check disappearance of anesthesia 6. Postoperative Analgesic Intake Efficacy of Tramadol hydrochloride as local anesthetic agent & its duration of action,its aneshetic potency & postoperative analgesic effect compared to lignocaine hydrochloride.	—

Measure

Time frame

Clinical Parameters: 1. Evaluation of the response (Allergic reaction) 2. Pain on injection 3. Onset of action 4. Peak Effect 5. Total duration of anaesthesia 6. Postoperative Analgesic IntakeTimepoint: Clinical Parameters: 1. Evaluation of the response (Allergic reaction)-15-20 minute 2. Pain on injection 3. Onset of action-every 10 second interval 4. Peak Effect- 5. Total duration of anaesthesia- every 5 minute until to check disappearance of anesthesia 6. Postoperative Analgesic Intake Efficacy of Tramadol hydrochloride as local anesthetic agent & its duration of action,its aneshetic potency & postoperative analgesic effect compared to lignocaine hydrochloride.

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Countries

India

Contacts

Public ContactDR SHUBHAM DILIP PHADTARE

RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL

narahari2012@yahoo.com9342519662

Outcome results

None listed

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