Efficacy of preemptive ibuprofen combined with paracetamol in lower third molar surgery: a double-blind randomized controlled clinical trial

Phase 4

Completed

• Conditions: Postoperative pain severity after third molar surgery will be moderate to severe pain during 6-12 hr. postoperatively. Analgesic drugs used after surgery do not be effective pain reduction.; Postoperative pain , third molar surgery

• Registration Number: TCTR20210604006
• Lead Sponsor: /A

Brief Summary

Preemptive ibuprofen 400 mg combined with paracetamol 500 mg did not improve analgesia after lower third molar surgery. However, it could extend the period of peak pain and the time at first requirement for rescue medications.

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-04-24
• Study Start: 2021-06-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1. Healthy (American Society of Anesthesiologists (ASA) classification I and II)
2. Age 18 to 30 years
3. Clear indication for removal of lower third molars
4. Moderate difficulty of lower third molar (Pederson 's difficulty index 5 to 6 score)
5. An absence of periodontal disease, infection, swelling prior to surgery

Exclusion Criteria

1.A history of hypersensitivity to NSAIDs and/or paracetamol
2.Taking analgesic medications, such as aspirin, paracetamol, NSAIDs, opioids, or any other agents that could confound the analgesic and safety/tolerability responses; the washout periods were between 24 hours and 2 weeks, depending on the half-life of the respective medications.
3.Taking medications known to interact with the study medications.
4.Patients with a history of severe asthma, gastrointestinal disorders such as gastric ulceration; hematologic, renal or hepatic disease; immunosuppressive disorder; neurological disorder affecting pain perception
5.Pregnant or lactating women
6.Smoker

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain score (visual analog scale) 5 years millimeter,Number of pain free patient 5 years number,Time at first requirement for rescue medications 5 years minute,Number of patients who received rescue medications 5 years number,Drug satisfaction (visual analog scale) 5 years millimeter

Secondary Outcome Measures

Name	Time	Method
Facial swelling 5 years millimeter,Mouth opening 5 years millimeter