Does Preventive Dexketoprofen Reduce Pain After Orthognathic Surgery

NCT ID: NCT05303688

Last Updated: 2022-03-31

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-02-01

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.

Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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)

Group Type EXPERIMENTAL

iv dexketoprofen trometamol (Arveles 50mg/2mL; UFSA, İstanbul, Turkey)

Intervention Type DRUG

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)

Group Type PLACEBO_COMPARATOR

Steril Salin (control)

Intervention Type DRUG

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

Intervention Type DRUG

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).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients,
* 18-45-year-olds,
* ASA I status,
* Class III malocclusion,
* elective double jaw surgery.

Exclusion Criteria

* drug allergy,
* liver and kidney failure,
* pregnant or breastfeeding,
* long-term use of pain relievers such as NSAIDs and opioids,
* diabetes
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Yusuf Nuri Kaba

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yusuf Nuri Kaba

Kayseri, Melikgazi, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Erü Dentistry

Identifier Type: -

Identifier Source: org_study_id

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