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Cold Press Test and Post Operative Pain Relationship

Primary Purpose

Post-operative Pain, Acute, Pain Threshold

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mandibular Third Molar Surgery
Sponsored by
Sinem Büşra Kıraç Can
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Post-operative Pain, Acute focused on measuring Cold Pressor Test, Post-operative Pain, Mandibular Third Molar

Eligibility Criteria

16 Years - 35 Years (Child, Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Marmara University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

The group who removed their hands from ice packs before 240 seconds

The group that can keep their hands on ice packs for 240 seconds

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Measurement of Post-Operative Pain
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

Measurement of Painkiller Use In The Post Operative Period
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.

Full Information

First Posted
June 6, 2023
Last Updated
June 13, 2023
Sponsor
Sinem Büşra Kıraç Can
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1. Study Identification

Unique Protocol Identification Number
NCT05904873
Brief Title
Cold Press Test and Post Operative Pain Relationship
Official Title
Can a Preoperative Cold Press Test be a Predictor of Pain After Third Molar Surgery?
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 7, 2021 (Actual)
Primary Completion Date
June 2, 2022 (Actual)
Study Completion Date
December 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sinem Büşra Kıraç Can

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain, Acute, Pain Threshold
Keywords
Cold Pressor Test, Post-operative Pain, Mandibular Third Molar

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Masking Description
The researcher who performs the ice test and the researcher who performs the surgical procedures are different from each other. The researcher performing the surgical procedure cannot know the ice test results of the participants.
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The group who removed their hands from ice packs before 240 seconds
Arm Type
Experimental
Arm Description
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.
Arm Title
The group that can keep their hands on ice packs for 240 seconds
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Mandibular Third Molar Surgery
Intervention Description
All surgical procedures were carried out by a single dental(maxillofacial) surgeon different from the clinician performing the cold testing. A total of 4 cc of local anesthetic solution containing 40 mg/ml articaine and 0.005 mg/ml epinephrine was applied to the inferior alveolar and buccal nerve blocks before the surgical procedure. In all cases, the mucoperiosteal flap was raised and bone was removed from the buccal and distal parts of the impacted tooth with burs, while protecting the papilla between the first and second molars during flap design. Before extraction, if necessary, the third molar was divided and tooth extraction was performed with elevators. The flap was brought to its original position and closed with silk suture material.
Primary Outcome Measure Information:
Title
Measurement of Post-Operative Pain
Description
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.
Time Frame
4 days
Secondary Outcome Measure Information:
Title
Measurement of Painkiller Use In The Post Operative Period
Description
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.
Time Frame
4 days

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Gonadal hormones are hypothesized to contribute to greater clinical and experimental pain experience in female patients compared to male patients. Therefore, the study group consisted of male patients only.
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sinem Busra Kirac Can
Organizational Affiliation
Marmara University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gülcan Berkel, Asist Prof
Organizational Affiliation
Marmara University
Official's Role
Study Director
Facility Information:
Facility Name
Marmara University
City
Istanbul
ZIP/Postal Code
34854
Country
Turkey

12. IPD Sharing Statement

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Cold Press Test and Post Operative Pain Relationship

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