Efficacy and Safety of Two Fixed-Dose Combinations of Tramadol Hydrochloride and Diclofenac Sodium in Postoperative Dental Pain

Pain Medicine ◽  
2020 ◽  
Vol 21 (10) ◽  
pp. 2447-2457
Author(s):  
Paul Desjardins ◽  
Fabian Alvarado ◽  
Martha Gil ◽  
Manuel González ◽  
Rogelio Guajardo
Keyword(s):  
Pain Relief ◽  
Diclofenac Sodium ◽  
Third Molar ◽  
Analgesic Efficacy ◽  
Fixed Dose ◽  
Efficacy And Safety ◽  
Tramadol Hydrochloride ◽  
Third Molar Extraction ◽  
Postoperative Dental Pain ◽  
The Individual

Abstract Objective To evaluate the analgesic efficacy and safety of tramadol hydrochloride/diclofenac sodium fixed-dose combination 25 mg/25 mg (FDC 25/25) and 50 mg/50 mg (FDC 50/50) vs tramadol 50 mg (T50) and diclofenac 50 mg (D50) monotherapies in acute postoperative dental pain. Setting Eight sites across Mexico. Subjects Adults (N = 829) with moderate to severe pain after third molar extraction. Design Prospective, randomized, double-blind, diclofenac- and tramadol-controlled, parallel-group, noninferiority, phase 3 trial. Methods Subjects were randomized to receive three doses (one every eight hours) of oral FDC 25/25, FDC 50/50, T50, or D50 over a 24-hour period. Pain intensity and pain relief were evaluated frequently over the 24 hours postdose. Secondary measures included peak pain relief, onset, and duration of effect. The primary objective was to compare the analgesic efficacy and safety of FDC 50/50 or analgesic noninferiority of FDC 25/25 vs D50 or T50. The primary efficacy end point was total pain relief over four hours after dose 1 (TOTPAR4). Results TOTPAR4 scores showed that FDC 25/25 was noninferior (P < 0.0001, delta = 1.5) and FDC 50/50 was superior (P < 0.0001) to the individual components. All secondary efficacy measures supported these results. The safety profile of FDC 25/25 and FDC 50/50 was consistent with the known safety profile of D50 and T50 monotherapies, with no unexpected safety findings observed. Conclusions Tramadol/diclofenac FDC 25/25 and FDC 50/50 provide superior analgesia for acute pain after third molar extraction than either of the individual components. Minor adverse effects appeared to be related to the higher doses of tramadol.

An Open-Label, Analgesic Efficacy and Safety of Pituitary Radiosurgery for Patients With Opioid-Refractory Pain: Study Protocol for a Randomized Controlled Trial

Neurosurgery ◽  
2017 ◽  
Vol 83 (1) ◽  
pp. 146-153 ◽  
Author(s):  
Pierre-Yves Borius ◽  
Stéphanie Ranque Garnier ◽  
Karine Baumstarck ◽  
Frédéric Castinetti ◽  
Anne Donnet ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pain Relief ◽  
Cancer Pain ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Standards Of Care ◽  
Control Group ◽  
Efficacy And Safety ◽  
Open Label

Abstract BACKGROUND Hypophysectomy performed by craniotomy or percutaneous techniques leads to complete pain relief in more than 70% to 80% of cases for opioid refractory cancer pain. Radiosurgery could be an interesting alternative approach to reduce complications. OBJECTIVE To assess the analgesic efficacy compared with standard of care is the primary goal. The secondary objectives are to assess ophthalmic and endocrine tolerance, drug consumption, quality of life, and mechanisms of analgesic action. METHODS The trial is multicenter, randomized, prospective, and open-label with 2 parallel groups. This concerns patients in palliative care suffering from nociceptive or mixed cancer pain, refractory to standard opioid therapy. Participants will be randomly assigned to the control group receiving standards of care for pain according to recommendations, or to the experimental group receiving a pituitary GammaKnife (Elekta, Stockholm, Sweden) radiosurgery (160 Gy delivered in pituitary gland) associated with standards of care. Evaluation assessments will be taken at baseline, day0, day4, day7, day14, day28, day45, month3, and month6. EXPECTED OUTCOMES We could expect pain improvement in 70% to 90% of cases at day4. In addition we will assess the safety of pituitary radiosurgery in a vulnerable population. The secondary endpoints could show decay of opioid consumption, good patient satisfaction, and improvement of the quality of life. DISCUSSION The design of this study is potentially the most appropriate to demonstrate the efficacy and safety of radiosurgery for this new indication. New recommendations could be obtained in order to improve pain relief and quality of life.

scholarly journals Comparison of intramuscular diclofenac sodium, diclofenac sodium suppository and intravenous tramadol for postoperative analgesia in gynaecological surgeries done under spinal anaesthesia

2018 ◽  
Vol 6 (9) ◽  
pp. 3034
Author(s):  
Sonali Mahendra Khobragade
Keyword(s):  
Blood Pressure ◽  
Postoperative Pain ◽  
Spinal Anaesthesia ◽  
Postoperative Analgesia ◽  
Diclofenac Sodium ◽  
Tertiary Care ◽  
Analgesic Efficacy ◽  
Care Hospital ◽  
Tramadol Hydrochloride ◽  
Sodium Diclofenac

Background: Postoperative pain management is a vital factor contributing towards speedy recovery of the patient in the perioperative period without significant morbidity. The purpose of this study was to compare the analgesic efficacy and safety of three most frequently used analgesic drugs-intramuscular diclofenac sodium, diclofenac suppository and intravenous tramadol hydrochloride in patients undergoing gynaecological surgeries.Methods: A hospital based, prospective, randomized, comparative study was undertaken in tertiary care hospital for a period of two years. The study included 90 adult patients undergoing gynaecological surgeries in spinal anaesthesia. Postoperative pain intensity was assessed by visual analogue scale. Level of sedation was assessed by four point scale along with haemodynamics.Results: There were no significant changes in the pulse rate, systolic blood pressure and diastolic blood pressure after giving I.M. diclofenac, diclofenac suppository and I.V. tramadol. The mean VAS scores were comparable in all three groups (p>0.05). The level of sedation was more in tramadol group than in diclofenac intramuscular and rectal group which was statistically significant (p=0.001).Conclusions: Diclofenac suppository provides effective postoperative analgesia when compared with Inj. Diclofenac I.M. and Inj. tramadol I.V. in patients undergoing infraumbilical gynaecological surgeries with stable vitals and no side effects.

Oral pregabalin for postoperative pain relief after third molar extraction: a randomized controlled clinical trial

2015 ◽  
Vol 20 (7) ◽  
pp. 1819-1826 ◽  
Author(s):  
Maria Victoria Olmedo-Gaya ◽  
Francisco J. Manzano-Moreno ◽  
Rafael Galvez-Mateos ◽  
Maria Paloma González-Rodriguez ◽  
Cristina Talero-Sevilla ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Postoperative Pain ◽  
Pain Relief ◽  
Third Molar ◽  
Postoperative Pain Relief ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Third Molar Extraction ◽  
Molar Extraction

scholarly journals ANALGESIC EFFICACY;

2012 ◽  
Vol 19 (06) ◽  
pp. 854-858
Author(s):  
ABRAR HUSSAIN KHOSA ◽  
NADEEM AHMED KHAN ◽  
HAQ DAD DURRANI ◽  
Zahra Wadoo
Keyword(s):  
Atomic Energy Commission ◽  
Diclofenac Sodium ◽  
Third Molar ◽  
Analgesic Efficacy ◽  
Maternity Hospital ◽  
T Test ◽  
Third Molar Surgery ◽  
P Value ◽  
Group I ◽  
Mean Time

Aim: To compare the analgesic efficacy of a single dose preoperative intramuscular Ketorolac versus diclofenac sodium forprevention of postoperative pain after third molar surgery. Design: This Experimental comparative study. Setting: Department of Anesthesia,Pakistan Atomic Energy Commission, Al-Zahra Hospital, Geo Care, and Maryam Maternity Hospital, DG Khan. Period: October 2011 to March2012. Material and Method: Patients undergoing elective third molar surgery were randomly assigned into one of the two groups. In eachgroup, 60 patients completed the study properly. Group-I received diclofenac sodium 75 mg IM 20 min preoperatively and group-II receivedKetorolac 30 mg IM 20 min preoperatively. Result: Patient in Ketorolac group reported significantly lesser pain intensity scores in the 3rd hourpain than the Diclofenac group (p-value lesser than 0.0001). Patient also reported significantly longer mean time to rescue analgesic 7.5 hversus 4.8h (p lesser than 0.001., student t test) that is approximately 2.5 h longer duration of preventive analgesic consumption (p=0.006,student t test). Conclusions: Preoperative intramuscular injection of Ketorolac 30 mg is more effective than Diclofenac 75 mg in the preventionof post operative 3rd molar pain.

Double-blind, randomized controlled clinical trial on analgesic efficacy of local anesthetics articaine and bupivacaine after impacted third molar extraction

2018 ◽  
Vol 22 (9) ◽  
pp. 2981-2988 ◽  
Author(s):  
Maria Victoria Olmedo-Gaya ◽  
Francisco Javier Manzano-Moreno ◽  
Jose Luis Muñoz-López ◽  
Manuel Francisco Vallecillo-Capilla ◽  
Candela Reyes-Botella
Keyword(s):  
Clinical Trial ◽  
Local Anesthetics ◽  
Third Molar ◽  
Analgesic Efficacy ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Double Blind ◽  
Impacted Third Molar ◽  
Randomized Controlled ◽  
Third Molar Extraction

scholarly journals Evaluation of efficacy of submucosal tramadol after mandibular third molar surgery: a prospective pilot study

2019 ◽  
Vol 7 (11) ◽  
pp. 4320
Author(s):  
Karan V. Panchal ◽  
Navin S. Shah ◽  
Pratik Agrawal ◽  
Parshwa N. Shah
Keyword(s):  
Pilot Study ◽  
Maxillofacial Surgery ◽  
Third Molar ◽  
Mouth Opening ◽  
Analgesic Efficacy ◽  
Third Molar Surgery ◽  
Oral And Maxillofacial Surgery ◽  
Third Molar Extraction ◽  
Mandibular Third Molar ◽  
Surgical Extraction

Background: Surgical extraction of mandibular third molar is one of the most commonly performed procedure in oral and maxillofacial surgery. Its removal causes swelling, trismus, and moderate to severe pain which can be treated with various NSAID’s drugs, which have numerous side effects and gastric disturbances. In order to bypass such disturbances, Tramadol may be considered as an alternative for such patients. The aim of the study was to evaluate analgesic efficacy of submucosal tramadol and its implication over swelling and mouth opening after mandibular third molar surgery.Methods: This is a prospective study where in after post-surgical extraction of mandibular third molar, efficacy of submucosal injection of tramadol is evaluated in terms of pain and its implication over swelling and mouth opening.Results: The present study suggested there was statistically significant VAS score for pain after submucosally injecting tramadol post-surgical extraction of mandibular third molar in the following visits- 4hourly, 8hourly and 24hourly. In respect to swelling, statistically significant values was noted during 24hr and 72 h our post extraction. Also in case of mouth opening, statistically significant values were found 24 hourly.Conclusions: The present pilot study concluded that submucosal tramadol post mandibular third molar extraction has been effective in reducing pain, limiting post-extraction swelling and less impacting mouth opening by inducing less complications thereby bypassing gastric disturbances.

Analgesic efficacy and safety of intravenous paracetamol (acetaminophen) administered as a 2 g starting dose following third molar surgery

2006 ◽  
Vol 10 (4) ◽  
pp. 371-371 ◽  
Author(s):  
Gitte I. Juhl ◽  
Sven E. Norholt ◽  
Else Tonnesen ◽  
Odile Hiesse-Provost ◽  
Troels S. Jensen
Keyword(s):  
Third Molar ◽  
Analgesic Efficacy ◽  
Third Molar Surgery ◽  
Efficacy And Safety ◽  
Intravenous Paracetamol ◽  
Starting Dose
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