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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lithuania
  • Kaunas, Lithuania, 47181
    • Lithuanian University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study; Receives pre-emptive analgesia 30min. prior to third molar extraction. NSAID: Ibuprofen 400mg and Acetaminophen 500mg/	Drug: Ibuprofen 400 mg and Acetaminophen 500 mg; Analgesia.
Placebo Comparator: Placebo; Receives glucose tablets as pre-emptive analgesia 30min. prior to third molar extraction.	Drug: Glucose; Placebo.
Active Comparator: Control; Receives no medication prior to third molar extraction.	Other: No drug; Standard surgical procedure without any preoperative medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-emptive analgesia is effective in a negative psycho-emotional status patients	Pre-emptive analgesia prior to third molard extraction is effective in different psycho-emotional status patients	4 months

Collaborators and Investigators

• Sponsor: Lithuanian University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): May 30, 2019

Study Registration Dates

• First Submitted: December 15, 2019
• First Submitted That Met QC Criteria: December 15, 2019
• First Posted (Actual): December 17, 2019

Study Record Updates

• Last Update Posted (Actual): December 17, 2019
• Last Update Submitted That Met QC Criteria: December 15, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ibuprofen
• Other Study ID Numbers: 5995

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