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

Pre-emptive Analgesia in Different Psycho-emotional Status Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04202224
• Other study ID #: 5995
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: May 30, 2019

Study information

• Verified date: December 2019
• Source: Lithuanian University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 30, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pre-emptive Analgesia in Different Psycho-emotional Status Patients

Intervention

Drug:
• Ibuprofen 400 mg and Acetaminophen 500 mg
Analgesia.
• Glucose
Placebo.

Other:
• No drug
Standard surgical procedure without any preoperative medication.

Locations

Country	Name	City	State
Lithuania	Lithuanian university of health sciences	Kaunas

Sponsors (1)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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