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

Primary Purpose

Pre-emptive Analgesia in Different Psycho-emotional Status Patients

Status
Completed
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Ibuprofen 400 mg and Acetaminophen 500 mg
Glucose
No drug
Sponsored by
Lithuanian University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pre-emptive Analgesia in Different Psycho-emotional Status Patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Lithuanian university of health sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Study

Placebo

Control

Arm Description

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

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

Receives no medication prior to third molar extraction.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 15, 2019
Last Updated
December 15, 2019
Sponsor
Lithuanian University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04202224
Brief Title
Pre-emptive Analgesia Effect in Different Psycho-emotional Status Patients During Lower Third Molar Surgical Extractions
Official Title
Pre-emptive Analgesia Effect in Different Psycho-emotional Status Patients During Lower Third Molar Surgical Extractions
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
May 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lithuanian University of Health Sciences

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-emptive Analgesia in Different Psycho-emotional Status Patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study
Arm Type
Experimental
Arm Description
Receives pre-emptive analgesia 30min. prior to third molar extraction. NSAID: Ibuprofen 400mg and Acetaminophen 500mg/
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Receives glucose tablets as pre-emptive analgesia 30min. prior to third molar extraction.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Receives no medication prior to third molar extraction.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen 400 mg and Acetaminophen 500 mg
Intervention Description
Analgesia.
Intervention Type
Drug
Intervention Name(s)
Glucose
Intervention Description
Placebo.
Intervention Type
Other
Intervention Name(s)
No drug
Intervention Description
Standard surgical procedure without any preoperative medication.
Primary Outcome Measure Information:
Title
Pre-emptive analgesia is effective in a negative psycho-emotional status patients
Description
Pre-emptive analgesia prior to third molard extraction is effective in different psycho-emotional status patients
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Lithuanian university of health sciences
City
Kaunas
ZIP/Postal Code
47181
Country
Lithuania

12. IPD Sharing Statement

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

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