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Study in patients of 3rd molar surgery for pain relief

A PROSPECTIVE RANDOMIZED PARALLEL GROUP ACTIVE CONTROLLED OPEN LABEL STUDY TO EVALUATE THE EFFECT OF ADD-ON PREGABALIN OVER STANDARD ANALGESIC TREATMENT IN THE CONTROL OF DENTAL PAIN AFTER 3RD MOLAR SURGERY

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/10/016145
Enrollment
100
Registered
2018-10-25
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: M267- Dental alveolar anomalies

Interventions

Intervention1: Pregabalin: Pregabalin 75 mg single dose 1 hour post surgery add on with aceclofenac 100mg BD for three days. Intervention2: pregabalin: Pregabalin 150 mg single dose 1 hour post surger

Sponsors

All India Institute of Medical Sciences AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient age between 18 to 50 years Impacted third molar teeth (grade 2nd& 3rd according to Parantâ??s classification) scheduled for surgical removal under local anesthesia will be included in the study. Patient literate enough and willing to adhere to requirement of the study procedure.

Exclusion criteria

Exclusion criteria: Patients with h/o chronic renal failure (Serum creatinine > 3mg% or patient on hemodialysis)., Pregnancy or breastfeeding, Allergy to the study medication or related drugs, Patients with h/o HIV or hepatitis B or hepatitis C infection. Patients with h/o Psychological disorder, Epilepsy, ï?¼ Receipt of medication with analgesic or anti-inflammatory properties in past 24 h before the surgery, Preoperative inflammation and pain at the surgical site and clinical or radiographic evidence of active oral disease.

Design outcomes

Primary

MeasureTime frame
To evaluate the efficacy of add-on oral pregabalin (75 mg single dose) with Aceclofenac (100 mg) vs. add-on oral pregabalin (150 mg single dose) with Aceclofenac (100 mg) vs.Aceclofenac (100 mg) alone in post-operative after 3rd molar surgeryTimepoint: From baseline to seven days

Secondary

MeasureTime frame
To count the number of rescue medication required in each group for adequate pain control To evaluate the incidence of drug related adverse events in all groups. Timepoint: From baseline to seven days

Countries

India

Contacts

Public ContactRavi Prakash Sharma

AIIMS RESIDENTIAL COMPLEX

drravisharma82@gmail.com8390985599

Outcome results

None listed

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