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Clinical Trials/NCT04769557
NCT04769557CompletedPhase 4

Pre-emptive Analgesics for Additional Pain Relief in Impacted Third Molar Surgery by depositing4% Articaine With 1:200000 Epinephrine Using Vazirani-Akinosi Closed Mouth Technique- A Randomized Clinical Trial

Melaka Manipal Medical College1 site in 1 country60 target enrollmentStarted: March 4, 2017Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
intraoperative pain

Study Overview

Brief Summary

The purpose of the study is to evaluate the efficacy of pre-emptive paracetamol in reducing intra operative pressure and post operative pain after surgical removal of impacted mandibular third molar using visual analogue scale

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Patients aged 21 years and above
  • Healthy patients (ASA I)
  • Patients who are not allergic to the drugs and local anesthetic agents used

Exclusion Criteria

  • Patients who are on concurrent treatment with NSAIDs or corticosteroids
  • Patients with pericoronitis or periapical infection

Arms & Interventions

Paracetamol

Experimental

Paracetamol

Intervention: paracetamol (Drug)

Placebo

Placebo Comparator

placebo

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

intraoperative pain

Time Frame: during luxation of tooth

A 10 mm Visual Analogue Scale with higher score depicting severe pain

postoperative pain

Time Frame: 1 day

A 10 mm Visual analogue scale with higher score depicting severe pain

Secondary Outcomes

  • Time to rescue medication(upto 360 minutes)
  • number of patients taking rescue medications(Upto 360 minutes)

Investigators

Sponsor
Melaka Manipal Medical College
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Abdul Kalam Azad

Assistant Professor

Melaka Manipal Medical College

Study Sites (1)

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