Pain Control Following Third Molar Surgery

July 21, 2024 updated by: Kamis Gaballah, University of Sharjah

Pain Control Following Impacted Mandibular Third Molar Surgery: A Comparison of the Effectiveness of Two Different Protocols

In this study, the investigators recruited patients undergoing surgical removal of impacted third molar teeth. Participants will be randomly divided into two groups Group 1: The patient will receive 400mg of ibuprofen plus 1000mg of Paracetamol simultaneously every 8 hours for two days.

Group 2- The patient will receive 400mg ibuprofen and 1000mg Paracetamol at 4 hours in intervals for two days. With a total of 3 doses of ibuprofen and 3 doses of paracetamol per day Then, pain control will be assessed using various primary and secondary outcome scales.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Surgical removal of an impacted mandibular third molar is one of the most common procedures in oral and maxillofacial surgery. Ten million third molars are extracted from approximately 5 million people in the United States each year. Research suggests that wisdom tooth removal has an immediate negative impact on patients' working and social lives: in one study, patients took an average of 1.6 days off work, with over one-third of patients stating that the surgery had affected their performance at work. Postoperative complications may include swelling, bruising, and limited mouth opening, along with difficulty with eating, which can be a major concern to patients and has not been appreciated by healthcare professionals in the past. However, patients are often most concerned about postoperative pain, which may be severe. Approximately one in two patients will experience pain despite analgesic therapy, even one week after surgery. The inflammatory response to surgical trauma is associated with edema, discomfort, dehiscence, and trismus, and these factors may affect the patient's everyday life. The control of these symptoms is frequently based on pharmacological manipulation of local and systemic pain and inflammation mediators. Combining two analgesic agents with distinct mechanisms or sites of action, such as combining a peripherally acting analgesic with a centrally acting analgesic, has been advocated for many years. A common example is the analgesic formulation containing acetaminophen combined with the opioid hydrocodone or paracetamol with ibuprofen. The pain control of single showed that the maximum effect is recorded in the first 2 to 3 hours. Combining two agents tends to increase the effect for 6 to 8 hours. However, as both medication actions commence simultaneously in the latter combination, they are likely to fade in the same way. This may make the patient likely to overdose on such medicine to ensure the continuity of pain relief. This research aims to test the combination of classical pain medication but in a novel alternate way to minimize the dosage and avoid the risk of side effects and toxicity.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Early Phase 1

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

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 years,
  2. Need for surgical extraction of at least one fully or partially impacted lower third molar with a degree of difficulty of 5 points or more on the Pedersen scale,
  3. ASA I-II status according to the American Society of Anesthesiologists, and
  4. No allergy to the drugs under study.

Exclusion Criteria:

  1. Pregnancy
  2. Breastfeeding
  3. ASA III or above
  4. Consumption of antibiotics in the week before surgery; and
  5. Clinical evidence of acute infection on the day of surgical intervention
  6. Radiographic evidence of peri-radicular pathology in impacted teeth requiring extraction

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study
patient will receive 400mg ibuprofen and 1000mg Paracetamol at 4 hours in intervals for two days. With a total of 3 doses of ibuprofen and 3 doses of paracetamol per day
Drug: Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given together every 8 hours
Group 1- The patient will receive 400mg ibuprofen plus 1000mg Paracetamol simultaneously every 8 hours for two days.
Active Comparator: Control
The patient will receive 400mg of ibuprofen plus 1000mg of Paracetamol simultaneously every 8 hours for two days.
Drug: Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given alternatively every four hours
Group 2- The patient will receive 400mg ibuprofen and 1000mg Paracetamol at 4 hours in intervals for two days. With a total of 3 doses of ibuprofen and 3 doses of paracetamol per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: 48 hours

Pain was analyzed in 2 ways:

(1) as the mean of pain intensity VAS score evaluated at 0, 4, 8, 12, 24, 36, and 48 hours post-extraction. Range 0-10
48 hours
The maximum pain experienced by patients
Time Frame: 48 hours
a)No pain, b)Some pain, c)Noticeable pain and d)Extreme pain
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Onset of pain control
Time Frame: 48 hours
The time to analgesic onset is defined as the time between trial drug intake and the first report of pain relief,
48 hours
Duration of pain control
Time Frame: 48 hours
the time between the first report of perceptible and meaningful pain relief and pain reappearing,
48 hours
the rescue medicine intake
Time Frame: 48 hours
the time from trial drug intake to the intake of the first dose of the rescue medicine
48 hours

Collaborators and Investigators

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

Sponsor

University of Sharjah

Investigators

  • Principal Investigator: Kamis Gaballah, PhD, University of Sharjah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 1, 2024

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

July 8, 2024

First Submitted That Met QC Criteria

July 21, 2024

First Posted (Actual)

July 23, 2024

Study Record Updates

Last Update Posted (Actual)

July 23, 2024

Last Update Submitted That Met QC Criteria

July 21, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC-23-03-25-01-S

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The IPD can not be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Post Operative Pain

Clinical Trials on Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given together every 8 hours

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe