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

NCT ID: NCT04202224

Last Updated: 2019-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-05-30

Brief Summary

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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

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Conditions

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Pre-emptive Analgesia in Different Psycho-emotional Status Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Study

Receives pre-emptive analgesia 30min. prior to third molar extraction. NSAID: Ibuprofen 400mg and Acetaminophen 500mg/

Group Type EXPERIMENTAL

Ibuprofen 400 mg and Acetaminophen 500 mg

Intervention Type DRUG

Analgesia.

Placebo

Receives glucose tablets as pre-emptive analgesia 30min. prior to third molar extraction.

Group Type PLACEBO_COMPARATOR

Glucose

Intervention Type DRUG

Placebo.

Control

Receives no medication prior to third molar extraction.

Group Type ACTIVE_COMPARATOR

No drug

Intervention Type OTHER

Standard surgical procedure without any preoperative medication.

Interventions

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Ibuprofen 400 mg and Acetaminophen 500 mg

Analgesia.

Intervention Type DRUG

Glucose

Placebo.

Intervention Type DRUG

No drug

Standard surgical procedure without any preoperative medication.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lithuanian University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Tomas Puidokas

Practitioner

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lithuanian university of health sciences

Kaunas, , Lithuania

Site Status

Countries

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Lithuania

Other Identifiers

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5995

Identifier Type: -

Identifier Source: org_study_id