Cold Press Test and Post Operative Pain Relationship

Not Applicable

Completed

• Conditions: Pain Threshold; Post-operative Pain, Acute
• Interventions: Procedure: Mandibular Third Molar Surgery

• Registration Number: NCT05904873
• Lead Sponsor: Sinem Büşra Kıraç Can

Brief Summary

The goal of this clinical trial is to investigate whether it is possible to get a preliminary idea about the postoperative pain in the patient with the results of a practical cold press test applied to American Society of Anesthesiologists(ASA) 1 and 2, healthy, male patients aged 16-35 before extraction of the lower third molar. The main question it aims to answer are:

• Can post-operative pain be predicted with an cold test that can be applied more practically than conventional quantitative sensory tests applied preoperatively? Participants will need to keep their hands on ice for 240 seconds prior to third molar surgery. When they take their hands off the ice, they will be asked to describe their pain on the visual analog scale. After the operation, the participants are required to mark whether they use painkillers every 8 hours in their pain follow-up forms and the pain they feel according to the visual analog scale.

Depending on the endurance time of the participants to keep their hands on the ice; Two different groups were determined as less than 240 sec and equal to 240 sec. The pain scores and the amount of painkiller use between these two groups were compared with each other.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-07
• Primary Completion: 2022-06-02
• Study Completion: 2022-12-14
• Status Verified: 2023-06
• Study First Submitted: 2023-06-06
• Study First Submitted QC: 2023-06-13
• Last Update Submitted: 2023-06-13
• Study First Posted: 2023-06-15
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• The impacted third molar should be class 1 or 2 and position B according to Pell & Gregory classification.
• The impacted third molar should be asymptomatic.
• The impacted third molar should be located in the mandible and be in the mesioangular or vertical position.
• To be male gender
• To be in American Society of Anesthesiologists 1 or 2 classification
• To be between the ages of 16-35

Exclusion Criteria

• Intolerance to non-steroidal anti-inflammatory drugs
• Smoking more than 10 cigarettes a day
• Operation time exceeding 20 minutes
• Individuals who have performed third molar tooth extraction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The group that can keep their hands on ice packs for 240 seconds	Mandibular Third Molar Surgery	In our study, a cold pressor test was applied to the participants in order to measure the pain tolerance according to the time duration they could keep their hands on the ice pack before the operation. Participants were prepared for an ice test in another area other than the operation area. Participants were asked to place their hands on standardized ice packs and keep them on the ice pack for 240 seconds. It was also said that if they could not tolerate pain, they could remove their hands from the ice before 240 seconds. The participants were asked to express the pain as a number between 0 (no pain) and 10 (unbearable pain) according to the visual analog scale when they removed their hands from the ice pack. Participants were divided into two groups according to the time duration of ice test as less than 240 seconds and equal to 240 seconds.
The group who removed their hands from ice packs before 240 seconds	Mandibular Third Molar Surgery	In our study, a cold pressor test was applied to the participants in order to measure the pain tolerance according to the time duration they could keep their hands on the ice pack before the operation. Participants were prepared for an ice test in another area other than the operation area. Participants were asked to place their hands on standardized ice packs and keep them on the ice pack for 240 seconds. It was also said that if they could not tolerate pain, they could remove their hands from the ice before 240 seconds. The participants were asked to express the pain as a number between 0 (no pain) and 10 (unbearable pain) according to the visual analog scale when they removed their hands from the ice pack. Participants were divided into two groups according to the time duration of ice test as less than 240 seconds and equal to seconds.

Primary Outcome Measures

Name	Time	Method
Measurement of Post-Operative Pain	4 days	To measure postoperative pain, all participants were given a form to fill out after surgery. In the form, there were areas where the participant should indicate pain between 0 and 10 according to the VAS scale . Forms were collected from each participant at the end of 4 days after the operation.

Secondary Outcome Measures

Name	Time	Method
Measurement of Painkiller Use In The Post Operative Period	4 days	To measure the amount of painkillers used post-surgery, all participants were given a form to fill out. In the form, there were areas where the participant should mark the use of ibuprofen in the first 0-2 hours and then every 8 hours. If paracetamol, which is the rescue medicine, is used, it was requested to mark the time and date in the table in the last part of the form. Forms were collected from each participant at the end of 4 days after the operation.

Trial Locations

Locations (1)

Marmara University; 🇹🇷 Istanbul, Turkey