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CompletedNCT04769557Updated Feb 24, 2021

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

A Phase 4 interventional study of paracetamol and Placebo in Impacted Third Molar Tooth, sponsored by Melaka Manipal Medical College. Completed at 1 site in Malaysia. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-24.

Sponsored by Melaka Manipal Medical College · Phase 4, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 years 11 months after the study started (first participant enrolled Mar 2017, registered Feb 2021).
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Impacted Third Molar Tooth
03

In context

Lead sponsor

Melaka Manipal Medical College is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients who are on concurrent treatment with NSAIDs or
  • Patients with pericoronitis or periapical infection
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Paracetamol

    Paracetamol

    Drug: paracetamol

  • Placebo comparator
    Placebo

    placebo

    Drug: Placebo

Interventions

  • tablet paracetamol 500 mg

    Also known as: Paracetamol 500 mg

  • DrugPlacebo

    placebo

06

What researchers measure

Primary outcomes

  1. intraoperative pain

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

    Time frame: during luxation of tooth

  2. postoperative pain

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

    Time frame: 1 day

Secondary outcomes

  1. Time to rescue medication

    minutes

    Time frame: upto 360 minutes

  2. number of patients taking rescue medications

    Total number of patients taking rescue medications

    Time frame: Upto 360 minutes

07

Study locations

1 site
  • Melaka manipal medical college
    Melaka, 71510, Malaysia
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04769557
Lead sponsor
Melaka Manipal Medical College
Responsible party
Abdul Kalam Azad (Assistant Professor, Melaka Manipal Medical College) — Principal investigator
First posted
Feb 24, 2021
Start date
Mar 4, 2017
Primary completion
Feb 27, 2019
Completion
Feb 27, 2019
Last update
Feb 24, 2021

Study contacts

Abdul K azad, MDS
principal investigator · Melaka Manipal Medical College

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Acetaminophen

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