Does Preventive Dexketoprofen Reduce Pain After Orthognathic Surgery

Study Overview
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Brief Summary
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Background The purpose of this study was to evaluate the effect of a single-dose intravenous dexketoprofen administration for preventive analgesia on postoperative pain and reducing swelling in double jaw surgery. Material and Methods The authors designed a prospective, randomized, and double-blind cohort study. Patients who have Class III malocclusion were randomly divided in two groups. 50 mg intravenous dexketoprofen trometamol were administrated 30 minutes before incision in treatment group, while intravenous sterile saline was administrated 30 minutes before incision in placebo group. The primary predictor variable was treatment group. Primary outcomes were pain, swelling and 24-hour opioid intake. Patient- controlled analgesia with tramadol was given for management of postoperative pain. Other variables were demographic and operation related parameters. Visual analogue scale was used to evaluate postoperative pain. 3dMD Face System (3dMD, USA) was used to measure postoperative swelling. Data were analysed using two independent samples t test and Mann Whitney U test.

Official Title
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Does Preventive Single Dose of Intravenous Dexketoprofen Reduce Pain and Swelling After Orthognathic Surgery? A Prospective, Randomized, Double Blind Clinical Trial

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: iv dexketoprofen trometamol (Arveles 50mg/2mL; UFSA, İstanbul, Turkey)
* Drug: Steril Salin (control)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria for this study were as follows; patients, 18-45-year-olds, ASA I status, Class III malocclusion, elective double jaw surgery. Exclusion Criteria: Exclusion criteria were ASA II and above, drug allergy, liver and kidney failure, pregnant or breastfeeding, long-term use of pain relievers such as NSAIDs and opioids, diabetes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug: Dexketoprofen Tremetamol<br>50 mg iv dexketoprofen trometamol (Arveles 50mg/2mL; UFSA, Istanbul, Turkey) were administrated 30 minutes before incision in the treatment group (deksketoprofen trometamol n= 15) | Drug: iv dexketoprofen trometamol (Arveles 50mg/2mL; UFSA, İstanbul, Turkey)<br>* The primary predictor variable was preventive analgesia group. Patients were randomly divided in two groups. 50 mg iv dexketoprofen trometamol (Arveles 50mg/2mL; UFSA, İstanbul, Turkey) were administrated 30 minutes before incision in the treatment group (dexketoprofen trometamol n= 15<br>|
| Placebo Comparator: Drug: Steril Salin (control)<br>iv sterile saline were administrated 30 minutes before incision in the placebo group (saline n= 15) | Drug: Steril Salin (control)<br>* 30 minutes before incision in the treatment group (dexketoprofen trometamol n= 15) and iv sterile saline were administrated 30 minutes before incision in the placebo group (saline n= 15).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative 1st hours Pain Score on the Visual Analog Scale | The postoperative pain was assessed using a 10-cm visual analogue scale (VAS) at postoperative 1st hours. 0 represents least pain, 50 represents moderate pain, and 100 represents maximum pain. | postoperative 1st hours | 
| Postoperative 3rd hours Pain Score on the Visual Analog Scale | The postoperative pain was assessed using a 10-cm visual analogue scale (VAS) at postoperative 3rd hours. 0 represents least pain, 50 represents moderate pain, and 100 represents maximum pain. | postoperative 3rd hours. | 
| Postoperative 6th hours Pain Score on the Visual Analog Scale | The postoperative pain was assessed using a 10-cm visual analogue scale (VAS) at postoperative 6th hours.0 represents least pain, 50 represents moderate pain, and 100 represents maximum pain. | postoperative 6th hours. | 
| Postoperative 9th hours Pain Score on the Visual Analog Scale | The postoperative pain was assessed using a 10-cm visual analogue scale (VAS) at postoperative 9th hours.0 represents least pain, 50 represents moderate pain, and 100 represents maximum pain. | postoperative 9th hours. | 
| Postoperative 12th hoursPain Score on the Visual Analog Scale | The postoperative pain was assessed using a 10-cm visual analogue scale (VAS) at postoperative 12th hours. 0 represents least pain, 50 represents moderate pain, and 100 represents maximum pain. | postoperative 12th hours. | 
| Postoperative 24th hours Pain Score on the Visual Analog Scale | The postoperative pain was assessed using a 10-cm visual analogue scale (VAS) at postoperative 24th hours. 0 represents least pain, 50 represents moderate pain, and 100 represents maximum pain. | postoperative 24th hours. | 
| 3D measure of postoperative swelling | 3dMD Face System (3dMD, ATLANTA, GA, USA) was used for 3D imaging of postoperative swelling. The same clinician took the 3D images from patients in natural head position, maximum intercuspation and eyes open. The 3dMD Vultus Software (3dMD, Atlanta, GA) was used to analyse the images. The 3-month postoperative 3D image (t90) was selected as the reference image to compare with other images. After cutting and customizing the images by anatomical structures, scans t0-t30 were matched to the reference scan t90. The forehead, nasion, tragus, medial and lateral canthus were used for surface matching. After surface matching, the volume difference between the masks was calculated | 3D images were taken one (T0) day before surgery. | 
| 3D measure of postoperative swelling | 3dMD Face System (3dMD, ATLANTA, GA, USA) was used for 3D imaging of postoperative swelling. The same clinician took the 3D images from patients in natural head position, maximum intercuspation and eyes open. The 3dMD Vultus Software (3dMD, Atlanta, GA) was used to analyse the images. The 3-month postoperative 3D image (t90) was selected as the reference image to compare with other images. After cutting and customizing the images by anatomical structures, scans t0-t30 were matched to the reference scan t90. The forehead, nasion, tragus, medial and lateral canthus were used for surface matching. After surface matching, the volume difference between the masks was calculated | 3D images were taken 1 (T1) day after surgery. | 
| 3D measure of postoperative swelling | 3dMD Face System (3dMD, ATLANTA, GA, USA) was used for 3D imaging of postoperative swelling. The same clinician took the 3D images from patients in natural head position, maximum intercuspation and eyes open. The 3dMD Vultus Software (3dMD, Atlanta, GA) was used to analyse the images. The 3-month postoperative 3D image (t90) was selected as the reference image to compare with other images. After cutting and customizing the images by anatomical structures, scans t0-t30 were matched to the reference scan t90. The forehead, nasion, tragus, medial and lateral canthus were used for surface matching. After surface matching, the volume difference between the masks was calculated | 3D images were taken3 (T3) day after surgery. | 
| 3D measure of postoperative swelling | 3dMD Face System (3dMD, ATLANTA, GA, USA) was used for 3D imaging of postoperative swelling. The same clinician took the 3D images from patients in natural head position, maximum intercuspation and eyes open. The 3dMD Vultus Software (3dMD, Atlanta, GA) was used to analyse the images. The 3-month postoperative 3D image (t90) was selected as the reference image to compare with other images. After cutting and customizing the images by anatomical structures, scans t0-t30 were matched to the reference scan t90. The forehead, nasion, tragus, medial and lateral canthus were used for surface matching. After surface matching, the volume difference between the masks was calculated | 3D images were taken 7 (T7) day after surgery. | 
| 3D measure of postoperative swelling | 3dMD Face System (3dMD, ATLANTA, GA, USA) was used for 3D imaging of postoperative swelling. The same clinician took the 3D images from patients in natural head position, maximum intercuspation and eyes open. The 3dMD Vultus Software (3dMD, Atlanta, GA) was used to analyse the images. The 3-month postoperative 3D image (t90) was selected as the reference image to compare with other images. After cutting and customizing the images by anatomical structures, scans t0-t30 were matched to the reference scan t90. The forehead, nasion, tragus, medial and lateral canthus were used for surface matching. After surface matching, the volume difference between the masks was calculated | 3D images were taken 14 (T14) day after surgery. | 
| 3D measure of postoperative swelling | 3dMD Face System (3dMD, ATLANTA, GA, USA) was used for 3D imaging of postoperative swelling. The same clinician took the 3D images from patients in natural head position, maximum intercuspation and eyes open. The 3dMD Vultus Software (3dMD, Atlanta, GA) was used to analyse the images. The 3-month postoperative 3D image (t90) was selected as the reference image to compare with other images. After cutting and customizing the images by anatomical structures, scans t0-t30 were matched to the reference scan t90. The forehead, nasion, tragus, medial and lateral canthus were used for surface matching. After surface matching, the volume difference between the masks was calculated | 3D images were taken 21 (T21) day after surgery. | 
| 3D measure of postoperative swelling | 3dMD Face System (3dMD, ATLANTA, GA, USA) was used for 3D imaging of postoperative swelling. The same clinician took the 3D images from patients in natural head position, maximum intercuspation and eyes open. The 3dMD Vultus Software (3dMD, Atlanta, GA) was used to analyse the images. The 3-month postoperative 3D image (t90) was selected as the reference image to compare with other images. After cutting and customizing the images by anatomical structures, scans t0-t30 were matched to the reference scan t90. The forehead, nasion, tragus, medial and lateral canthus were used for surface matching. After surface matching, the volume difference between the masks was calculated | 3D images were taken 30 (T30) day after surgery. | 
| 3D measure of postoperative swelling | 3dMD Face System (3dMD, ATLANTA, GA, USA) was used for 3D imaging of postoperative swelling. The same clinician took the 3D images from patients in natural head position, maximum intercuspation and eyes open. The 3dMD Vultus Software (3dMD, Atlanta, GA) was used to analyse the images. The 3-month postoperative 3D image (t90) was selected as the reference image to compare with other images. After cutting and customizing the images by anatomical structures, scans t0-t30 were matched to the reference scan t90. The forehead, nasion, tragus, medial and lateral canthus were used for surface matching. After surface matching, the volume difference between the masks was calculated | 3D images were taken 90 (T90) day after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preventive analgesia, Pain, Swelling, Orthognathic surgery, Dexketoprofen, 3dMD