NCT04769557

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2019

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

2 years

First QC Date

February 6, 2021

Last Update Submit

February 21, 2021

Conditions

Impacted Third Molar Tooth

Outcome Measures

Primary Outcomes (2)

  • 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 (2)

  • Time to rescue medication

    upto 360 minutes

  • number of patients taking rescue medications

    Upto 360 minutes

Study Arms (2)

Paracetamol

EXPERIMENTAL

Paracetamol

Drug: paracetamol

Placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

paracetamolDRUG

tablet paracetamol 500 mg

Also known as: Paracetamol 500 mg
Paracetamol
PlaceboDRUG

placebo

Placebo

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Melaka manipal medical college

Malacca, 71510, Malaysia

Location

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Abdul K azad, MDS

    Melaka Manipal Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 6, 2021

First Posted

February 24, 2021

Study Start

March 4, 2017

Primary Completion

February 27, 2019

Study Completion

February 27, 2019

Last Updated

February 24, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP

Locations

MY(1)