Pre-emptive Analgesia Effect in Different Psycho-emotional Status Patients During Lower Third Molar Surgical Extractions

Not Applicable

Completed

• Conditions: Pre-emptive Analgesia in Different Psycho-emotional Status Patients
• Interventions: Other: No drug; Drug: Ibuprofen 400 mg and Acetaminophen 500 mg; Drug: Glucose

• Registration Number: NCT04202224
• Lead Sponsor: Lithuanian University of Health Sciences

Brief Summary

To increase the effectiveness of pain control, it is recommended to use drugs before the pain onset, therefore the pre-emptive analgesia method is considered as a method, which allows decreasing the post-operative pain to minimum. Previous studies evaluated effectiveness of pre-emptive analgesia but no relation to psycho-emotional status was addressed. Our authors believe that the effect of pre-emptive analgesia may vary based on different psycho-emotional status.

45 volunteers who needed extraction of lower third molars were examined and enrolled in the study (study group - 15; placebo - 15; control - 15 volunteers). Ibuprofen 400mg together with 500mg paracetamol was used for pre-emptive analgesia. Difficulty of the operation, heart rate measurements and operation protocol were documented. Surgeon filled his questionnaire after the procedure. Patients on consultation, operation day and 10 days postop. filled a questionnaire which consisted of general, special and pain evaluation sections. Less favorable psycho-emotional status correlated with more severe pain 6h after operation. This relation was mostly expressed in the control group. Psycho-emotional status of placebo patients was accounted for bigger analgesic consumption frequency. Postoperative pain in study group was minimal compared to other groups. Pre-emptive analgesia enhances patient's psycho-emotional status and sustains postoperative pain control during lower third molar surgical extractions.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Primary Completion: 2019-02-01
• Study Completion: 2019-05-30
• Status Verified: 2019-12
• Study First Submitted: 2019-12-15
• Study First Submitted QC: 2019-12-15
• Last Update Submitted: 2019-12-15
• Study First Posted: 2019-12-17
• Last Update Posted: 2019-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Adult patients;
• Indications for mandibular third molar removal.

Exclusion Criteria

• Presence of NSAID usage;
• Acute inflammation in operating site;
• General diseases that might negatively influence the outcomes of operation, such as epilepsy, unstable neurological condition;
• Anticoagulant usage;
• Diabetes mellitus;
• Cardiovascular diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control	No drug	Receives no medication prior to third molar extraction.
Study	Ibuprofen 400 mg and Acetaminophen 500 mg	Receives pre-emptive analgesia 30min. prior to third molar extraction. NSAID: Ibuprofen 400mg and Acetaminophen 500mg/
Placebo	Glucose	Receives glucose tablets as pre-emptive analgesia 30min. prior to third molar extraction.

Primary Outcome Measures

Name	Time	Method
Pre-emptive analgesia is effective in a negative psycho-emotional status patients	4 months	Pre-emptive analgesia prior to third molard extraction is effective in different psycho-emotional status patients

Trial Locations

Locations (1)

Lithuanian university of health sciences; 🇱🇹 Kaunas, Lithuania