Pain Control Following Third Molar Surgery

Early Phase 1

Active, not recruiting

• Conditions: Impacted Third Molar Tooth; Post Operative Pain
• Interventions: Drug: Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given together every 8 hours; Drug: Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given alternatively every four hours

• Registration Number: NCT06514222
• Lead Sponsor: University of Sharjah

Brief Summary

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.

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 Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-01
• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-21
• Last Update Submitted: 2024-07-21
• Study First Posted: 2024-07-23
• Last Update Posted: 2024-07-23
• Primary Completion: 2024-08-31
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study	Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given together every 8 hours	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
Control	Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given alternatively every four hours	The patient will receive 400mg of ibuprofen plus 1000mg of Paracetamol simultaneously every 8 hours for two days.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale	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
The maximum pain experienced by patients	48 hours	a)No pain, b)Some pain, c)Noticeable pain and d)Extreme pain

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University dental Hospital; 🇦🇪 Sharjah, United Arab Emirates