Pre Emptive Analgesics for Pain Relief in Impacted Lower... | NCT04769557

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

NCT04769557

Sponsor

Melaka Manipal Medical College

Status

Completed

Last Update Posted

Feb 24, 2021Actual

Enrollment

60Actual

Phase

Phase 4

Conditions

Impacted Third Molar Tooth

Interventions

paracetamol
Placebo

Countries

Malaysia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 4, 2017Actual

Primary Completion Date

Feb 27, 2019Actual

Completion Date

Feb 27, 2019Actual

First Submitted Date

Feb 6, 2021

First Submission Date that Met QC Criteria

Feb 21, 2021

First Posted Date

Feb 24, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2021

Last Update Posted Date

Feb 24, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Abdul Kalam Azad, Assistant Professor, Melaka Manipal Medical CollegePrincipal Investigator

Lead Sponsor

Melaka Manipal Medical CollegeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Paracetamol	Experimental	Paracetamol	Drug: paracetamol
Placebo	Placebo Comparator	placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
paracetamol	Drug	tablet paracetamol 500 mg	Paracetamol	Paracetamol 500 mg

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Abdul K azad, MDS	Melaka Manipal Medical College	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Melaka manipal medical college		Malacca		71510	Malaysia

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000082	Acetaminophen

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided