Back to resultsPre Emptive Analgesics for Pain Relief in Impacted Lower Third Molar Surgery
Primary Purpose
Impacted Third Molar Tooth
Status
Completed
Phase
Phase 4
Locations
Malaysia
Study Type
Interventional
Intervention
paracetamol
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Impacted Third Molar Tooth
Eligibility Criteria
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
Sites / Locations
- Melaka manipal medical college
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Paracetamol
Placebo
Arm Description
Paracetamol
placebo
Outcomes
Primary Outcome Measures
intraoperative pain
A 10 mm Visual Analogue Scale with higher score depicting severe pain
postoperative pain
A 10 mm Visual analogue scale with higher score depicting severe pain
Secondary Outcome Measures
Time to rescue medication
minutes
number of patients taking rescue medications
Total number of patients taking rescue medications
Full Information
NCT ID
NCT04769557
First Posted
February 6, 2021
Last Updated
February 21, 2021
Sponsor
Melaka Manipal Medical College
1. Study Identification
Unique Protocol Identification Number
NCT04769557
Brief Title
Pre Emptive Analgesics for Pain Relief in Impacted Lower Third Molar Surgery
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 4, 2017 (Actual)
Primary Completion Date
February 27, 2019 (Actual)
Study Completion Date
February 27, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Melaka Manipal Medical College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Third Molar Tooth
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paracetamol
Arm Type
Experimental
Arm Description
Paracetamol
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
paracetamol
Other Intervention Name(s)
Paracetamol 500 mg
Intervention Description
tablet paracetamol 500 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
intraoperative pain
Description
A 10 mm Visual Analogue Scale with higher score depicting severe pain
Time Frame
during luxation of tooth
Title
postoperative pain
Description
A 10 mm Visual analogue scale with higher score depicting severe pain
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Time to rescue medication
Description
minutes
Time Frame
upto 360 minutes
Title
number of patients taking rescue medications
Description
Total number of patients taking rescue medications
Time Frame
Upto 360 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdul K azad, MDS
Organizational Affiliation
Melaka Manipal Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Melaka manipal medical college
City
Melaka
ZIP/Postal Code
71510
Country
Malaysia
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Pre Emptive Analgesics for Pain Relief in Impacted Lower Third Molar Surgery
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