A clinical trial to study the effect of tramadol hydrochloride and lignocaine in symptomatic irreversible pulpitis.

Comparative Evaluation of Perioperative Analgesic and Anaesthetic Efficacy in Supraperiosteal Infiltration of Tramadol Hydrochloride in patients with Symptomatic Irreversible Pulpitis – A Triple-blind randomized controlled trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/070517

Enrollment

110

Registered

2024-07-12

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: K040- Pulpitis

Interventions

Intervention1: 50 mg/ml Tramadol Hydrochloride: Supraperiosteal infiltration(Infiltration anaesthesia) of tramadol HCL (50 mg/mL) solution will be administered at the buccal side with respect to the m

Eligibility

Inclusion criteria

Inclusion criteria: ASA I Pain severity with HP-VAS (85mm above) in maxillary molars.

Exclusion criteria

Exclusion criteria: ASA II and above Patients with allergy, sensitivity or side effects to tramadol or any opioid drugs. Negative response to electric pulp testing. Periodontally compromised teeth. Patients with bleeding disorders. Calcified root canals, root resorption, open apex or unrestorable teeth. Patients who consumed analgesics or antibiotics within 24 hours before the treatment.

Design outcomes

Primary

Measure	Time frame
To comparatively assess the perioperative analgesic efficacy of tramadol hydrochloride as a local anaesthetic agent in maxillary molars with symptomatic irreversible pulpitis using heft-parker visual analogue scale and brief pain inventory assessment tool.Timepoint: Intraoperative and 6, 12, 24 and 48 hr postoperative.	—

Secondary

Measure	Time frame
Perioperative analgesic efficacyTimepoint: 6, 12, 24 & 48 hr postoperative.	—

Countries

India

Contacts

Public ContactDr Mahalaxmi S

SRM Institute of Science and Technology

vijaya1@srmist.edu.in9884111167

Outcome results

None listed

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