Does Preventive Dexketoprofen Reduce Pain After Orthognathic Surgery
NCT ID: NCT05303688
Last Updated: 2022-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2018-03-01
2019-02-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Drug: Dexketoprofen Tremetamol
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)
iv dexketoprofen trometamol (Arveles 50mg/2mL; UFSA, İstanbul, Turkey)
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
Drug: Steril Salin (control)
iv sterile saline were administrated 30 minutes before incision in the placebo group (saline n= 15)
Steril Salin (control)
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).
Interventions
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iv dexketoprofen trometamol (Arveles 50mg/2mL; UFSA, İstanbul, Turkey)
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
Steril Salin (control)
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).
Eligibility Criteria
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Inclusion Criteria
* 18-45-year-olds,
* ASA I status,
* Class III malocclusion,
* elective double jaw surgery.
Exclusion Criteria
* liver and kidney failure,
* pregnant or breastfeeding,
* long-term use of pain relievers such as NSAIDs and opioids,
* diabetes
18 Years
45 Years
ALL
Yes
Sponsors
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TC Erciyes University
OTHER
Responsible Party
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Yusuf Nuri Kaba
Principal Investigator
Locations
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Yusuf Nuri Kaba
Kayseri, Melikgazi, Turkey (Türkiye)
Countries
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Other Identifiers
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Erü Dentistry
Identifier Type: -
Identifier Source: org_study_id
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