Pre Emptive Analgesics for Pain Relief in Impacted Lower Third Molar Surgery

February 21, 2021 updated by: Abdul Kalam Azad, Melaka Manipal Medical College

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
      • Melaka, Malaysia, 71510
        • Melaka Manipal Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
placebo
Drug: Placebo
placebo
Experimental: Paracetamol
Drug: paracetamol
tablet paracetamol 500 mg
Other Names:
  • Paracetamol 500 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative pain
Time Frame: during luxation of tooth
A 10 mm Visual Analogue Scale with higher score depicting severe pain
during luxation of tooth
postoperative pain
Time Frame: 1 day
A 10 mm Visual analogue scale with higher score depicting severe pain
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to rescue medication
Time Frame: upto 360 minutes
minutes
upto 360 minutes
number of patients taking rescue medications
Time Frame: Upto 360 minutes
Total number of patients taking rescue medications
Upto 360 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Melaka Manipal Medical College

Investigators

  • Principal Investigator: Abdul K azad, MDS, Melaka Manipal Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2017

Primary Completion (Actual)

February 27, 2019

Study Completion (Actual)

February 27, 2019

Study Registration Dates

First Submitted

February 6, 2021

First Submitted That Met QC Criteria

February 21, 2021

First Posted (Actual)

February 24, 2021

Study Record Updates

Last Update Posted (Actual)

February 24, 2021

Last Update Submitted That Met QC Criteria

February 21, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMMC/FOD/AR/B5/E C-2017(07)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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