Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05791721
Other study ID # 36/22
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 11, 2021
Est. completion date December 26, 2022

Study information

Verified date March 2023
Source University of Belgrade
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare preemptive single-dose selective cyclooxygenase 2 (COX-2) inhibitor - etoricoxib and dexamethasone use in systemically healthy patients during the surgical extraction of impacted mandibular third molars. The main questions it aims to answer/evaluate are: - the level of inflammatory and early wound healing mediators in patients' saliva during early postoperative phase - clinical postoperative parameters such as pain, swelling and trismus - patient satisfaction with the treatment - rescue medication consumed during the postoperative period - incidence of adverse events Participants indicated for mandibular third molar surgery will be asked to: - take premedication (etoricoxib or dexamethasone) before surgical extraction - provide saliva samples before and following the surgery at regular check-ups - note the amount of rescue medication taken and pain intensity in different time points - perform clinical measurements of swelling and trismus at regular check-up visits - answer the questions about satisfaction and potential adverse events, if occur Researchers will compare preemptive single-dose etoricoxib, preemptive single-dose dexamethasone, and no premedication in impacted mandibular third molar surgery, to see if there are differences in inflammatory response and early wound healing, as well as in clinical postoperative parameters, patient satisfaction with the treatment and incidence of potential adverse events.


Description:

Acute pain, swelling and trismus present typical clinical manifestation following impacted mandibular third molar surgery. Postoperative wound healing is regulated by activity of inflammatory mediators and osteogenic factors. Nonsteroidal anti-inflammatory drugs, especially cyclooxygenase 2 (COX-2) inhibitors and glucocorticoids are routinely used to improve postoperative clinical state of the patients. Studies have shown that both COX-2 inhibitors and dexamethasone may decrease the number of postsurgical rescue medication intake, reduce the postoperative edema and increase the mouth opening ability. Analgesic efficacy of etoricoxib (ETOX), a high selective COX-2 inhibitor has been shown as superior compared to placebo and other nonsteroidal anti-inflammatory drugs in third molar surgery. However, literature data on comparative testing of ETOX and dexamethasone (DEX) use in third molar surgery are scarce. Furthermore, no studies with a 7 days follow-up were conducted. Preclinical studies indicate that COX-2 inhibitors and DEX may negatively affect early wound healing by down-regulation of mediators such as COX-2, prostaglandin E2 (PGE2), alkaline phosphatase (ALP), runt-related transcription factor 2 (RUNX2), and osteocalcin (OCN). Specialized pro-resolving lipid mediators are important for resolution phase of inflammatory process and wound healing. According to animal studies, maresin 1 (MAR1) has important role in post-trauma pain reduction and bone healing, thus the expression of this mediator may be significant to indicate the course of postoperative wound healing. In the current literature, no data on salivary early bone healing mediators following preemptive use of ETOX and DEX in mandibular third molar removal are available. Moreover, the correlation of these markers, as well as inflammatory saliva mediators with the clinical parameters may be important for potential developing of future unique protocols for premedication in third molar surgery. The primary goal of the research will be to evaluate the level of inflammatory and early wound healing mediators (COX-2, PGE2, ALP, RUNX2, OCN, MAR1) in saliva samples obtained from the systemically healthy patients requiring impacted mandibular third molar extraction, in conditions of 1-preemptive single-dose ETOX 90 mg oral use; 2-preemptive single-dose DEX 4 mg intramuscular use, and 3-no premedication. Secondary outcomes will include correlation of mentioned salivary mediators with postoperative clinical parameters such as pain, swelling and trismus. Furthermore, rescue medication intake, patient satisfaction with the treatment, and incidence of potential adverse events will be recorded. A prospective, randomized, controlled, parallel-group, double-blinded clinical trial will be conducted at the Department of Oral surgery and Laboratory for basic science, School of Dental medicine, University of Belgrade, Serbia. The research will be performed following the CONSORT guidelines, per the Helsinki Declaration. Subjects who require unilateral fully impacted mandibular third molar extraction will be screened for eligibility. After meeting the inclusion criteria, participants will receive verbal and written information on the study objectives, protocol as well as the possible risks and benefits of the study. Only the eligible subjects who agree with the information provided and sign an informed consent form will be enrolled in the study. A total of 90 patients will be included (n=30). Computer-generated blocked randomization with a 1:1:1 allocation ratio (block size 6) will be performed by a researcher not included in the study (Microsoft Excel, version 2016). To conceal the allocation, the papers containing a code of the allocated group (1-ETOX group; 2-DEX group; 3-control group) will be sequentially packed in opaque envelopes and sealed. One hour before the intervention, the same independent researcher will unseal the following envelope and, depending on the study group, administer ETOX in a blurred plastic container (ETOX group), DEX in the unspecified syringe (DEX group), or provide written information on cold packs usage during the postoperative period (control group). The patients will be unaware of the generic and the brand name of the medications, but they will be notified that the drugs are registered and on the market. The allocation will be concealed until the finishing of the data analysis. The surgeon who will perform all the interventions and the researcher who will collect the data will be masked to the patients' allocations. After recruitment, data on age (years), sex, and smoking status (no smoking, ≤10/day, or >10/day) will be obtained from all the included patients. During the same visit, the surgical intervention will be scheduled, and the third molar position will be estimated on panoramic radiographs, according to the Pell and Gregory and Winter classifications. Initial exam, pre-, perioperative, and follow-up measurements will be performed by one blinded clinician. On the second study visit, one hour before surgical intervention, patients will be instructed to note the amount of pain experienced at that moment on a 10-cm long visual analog scale (VAS), where 0 means no pain at all and 10 represent the greatest pain they ever felt. A 6-point verbal rating pain scale (VRS) will be also provided to the patients to document the current pain (1-no pain; 2-mild pain; 3-moderate pain; 4-severe pain; 5-very severe pain; 6-the worst possible pain). Additionally, baseline measurements of a maximal inter-incisor and lobule-pogonion distance at the side of the extraction-required third molar in millimeters will be obtained by a soft tape measure. Afterward, 1 hour before the surgery patients will receive: single-dose ETOX 90 mg (Etoxib®, KRKA, Novo Mesto, Slovenia) orally (ETOX group); single-dose DEX 4 mg (Dexason®, Galenika, Belgrade, Serbia) in deltoid muscle (DEX group); no premedication (control group). After regional inferior alveolar, lingual, and buccal nerve blocks with a local anesthetic consisting of 4% articaine hydrochloride with 1:100000 epinephrine (Septanest®, Septodont, Saint-Maur-des-Fosses, France), the surgical removal of impacted mandibular third molar will be performed according to the technique previously described in the literature: after full-thickness flap elevation, bone removal will be performed by rotatory instruments under sterile saline irrigation. Instruments such as levers will be used for tooth extraction, and tooth separation will be performed, if necessary. After tooth extraction and bone edges smoothening, the wound will be primary sutured. All the surgical procedures will be performed by one experienced oral surgeon, masked to the allocation group. Perioperatively, the duration of the intervention (min), the amount of local anesthetic solution used (ml), tooth separation if performed, and any complications such as inferior alveolar vascular damage will be registered. Following the intervention, patients will be advised to take rescue medication if pain occurs at any time. Paracetamol 500 mg regimen will be prescribed as an escape analgesic (Paracetamol®, Galenika, Belgrade, Serbia), with the instructions to not exceed the maximal recommended daily dose (4000 mg). Additionally, the antibiotics will be prescribed: amoxicillin 500 mg or clindamycin 600 mg in case of penicillin hypersensitivity, three times a day for 5 days. Thereafter, all the patients will receive written hygienic-dietary instructions with the advice of careful oral hygiene maintenance, a soft diet, avoidance of mouth rinsing, as well as smoking, hot food, and hot beverages. The additional penned information for the control group will involve repeated use of cold packs with a 20-min pause, and will be submitted to the patients preoperatively. After surgery, patients will received a pre-designed take-home diary containing fields for rescue analgesic registration (every time of intake, number of the regimen, and dose) and a list of the most common adverse events (headache, nausea, vomiting, vertigo, insomnia, fever), with instructions to check any of the listed, or write down any other if occurred. Additionally, patients will be instructed to record pain intensity on VAS and VRS at 2h, 4h, 6h, 8h, 10h, 12h, and 72h following the surgery, as well as in every case of rescue medication intake. Control check-ups will be scheduled at 24h, 48h, and 7 days postoperatively. On each control examination, the 5-point Likert scale will be used to assess patient satisfaction at the respective time. The following question will be asked: "How satisfied are you at this moment with the impacted mandibular third molar surgery?", and the possible answers will be: "5-very satisfied", "4-satisfied", "3-neutral", "2-dissatisfied", and "1-very dissatisfied". After collecting the answers from every check-up visit, average patient satisfaction with the treatment will be calculated. During every control study visit, the severity of pain experiencing at that moment will be noted on VAS and VRS. Maximal inter-incisor and lobule-pogonion distance on the operated side will be measured. In addition, at a 7-day check-up the take-home diary will obtained from the patients. Samples containing 0,5 ml of unstimulated saliva will be collected from the floor of the mouth by means of 2 ml plastic syringe and dull needle of 18 Gauge thickness in four time points: One hour before surgery, immediately, 48h and 7 days after the surgery. Saliva samples will be collected in sterile plastic tubes that are pre-filled with fluid that prevents RNA degradation and stored at -80 degrees Celsius until laboratory analysis. Laboratory procedures will be performed with aim to assess the level of relative gene as well as protein expression of inflammatory (COX-2, PGE2) and early wound healing (RUNX2, ALP, OCN, MAR1) mediators in tested groups in different time points of interest. After RNA isolation and obtaining of complementary DNA (according to the manufacturer instructions), relative gene expression of COX-2, PGE2, RUNX2, ALP and OCN will be evaluated by means of real-time polymerase chain reaction assay. Protein expression of PGE2 and MAR1 will be performed by enzyme linked immunosorbent assay (ELISA). Statistical analysis will be performed in statistical package SPSS, version 22.0 (SPSS, Inc. Chicago). Data will be presented through mean, standard deviation, median, maximum and minimum values, percent. Depending of the data distribution, appropriate parametric or non-parametric tests will be performed. Regression models will be performed to determine the predictors of detected inter-group differences. The level of significance will be set at 0.05.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date December 26, 2022
Est. primary completion date December 26, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - Systemically healthy individuals (ASA I by American Society of Anesthesiologists classification); - Age 18-30 years; - Absence of hypersensitivity to any of the medications in the study; - Subjects capable to understand the protocol and sign an informed consent form. Exclusion Criteria: - Systemic disorders; - Individuals in gestation or lactation period; - Radiographic presence of potential cystic or tumorous lesions in the region of the extraction-required IMTM; - Any symptoms or clinical signs of the infection caused by the extraction-required IMTM up to 10 days preoperatively; - Use of NSAIDs or corticosteroids within 10 days before the surgery.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Etoricoxib 90 Mg Oral Tablet
Intervention will be applied one hour before surgical extraction of impacted mandibular third molar
Dexamethasone 4mg
Intervention will be applied one hour before surgical extraction of impacted mandibular third molar

Locations

Country Name City State
Serbia School of Dental medicine, University of Belgrade Belgrade

Sponsors (1)

Lead Sponsor Collaborator
University of Belgrade

Country where clinical trial is conducted

Serbia, 

References & Publications (1)

Martins-de-Barros AV, Barros AM, Siqueira AK, Lucena EE, Sette de Souza PH, Araujo FA. Is Dexamethasone superior to Ketorolac in reducing pain, swelling and trismus following mandibular third molar removal? A split mouth triple-blind randomized clinical trial. Med Oral Patol Oral Cir Bucal. 2021 Mar 1;26(2):e141-e150. doi: 10.4317/medoral.24088. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Relative gene expression of inflammatory and early wound healing salivary mediators during impacted mandibular third molar surgery in conditions of preemptive etoricoxib, dexamethasone, or no premedication use To measure the relative gene expression of COX-2, PGE2, ALP, RUNX2, OCN in saliva samples obtained 1 hour before surgical removal of impacted mandibular third molar 1 hour before surgery
Primary Protein expression of inflammatory and early wound healing salivary mediators during impacted mandibular third molar surgery in conditions of preemptive etoricoxib, dexamethasone, or no premedication use To measure the protein expression of PGE2 and MAR1 in saliva samples obtained 1 hour before surgical removal of impacted mandibular third molar 1 hour before surgery
Primary Relative gene expression of inflammatory and early wound healing salivary mediators during impacted mandibular third molar surgery in conditions of preemptive etoricoxib, dexamethasone, or no premedication use To measure the relative gene expression of COX-2, PGE2, ALP, RUNX2, OCN in saliva samples obtained immediately after surgical removal of impacted mandibular third molar immediately after surgery
Primary Protein expression of inflammatory and early wound healing salivary mediators during impacted mandibular third molar surgery in conditions of preemptive etoricoxib, dexamethasone, or no premedication use To measure the protein expression of PGE2 and MAR1 in saliva samples obtained immediately after surgical removal of impacted mandibular third molar immediately after surgery
Primary Relative gene expression of inflammatory and early wound healing salivary mediators during impacted mandibular third molar surgery in conditions of preemptive etoricoxib, dexamethasone, or no premedication use To measure the relative gene expression of COX-2, PGE2, ALP, RUNX2, OCN in saliva samples obtained 48 hours after surgical removal of impacted mandibular third molar 48 hours after surgery
Primary Protein expression of inflammatory and early wound healing salivary mediators during impacted mandibular third molar surgery in conditions of preemptive etoricoxib, dexamethasone, or no premedication use To measure the protein expression of PGE2 and MAR1 in saliva samples obtained 48 hours after surgical removal of impacted mandibular third molar 48 hours after surgery
Primary Relative gene expression of inflammatory and early wound healing salivary mediators during impacted mandibular third molar surgery in conditions of preemptive etoricoxib, dexamethasone, or no premedication use To measure the relative gene expression of COX-2, PGE2, ALP, RUNX2, OCN in saliva samples obtained on Day 7 after surgical removal of impacted mandibular third molar Day 7 after surgery
Primary Protein expression of inflammatory and early wound healing salivary mediators during impacted mandibular third molar surgery in conditions of preemptive etoricoxib, dexamethasone, or no premedication use To measure the protein expression of PGE2 and MAR1 in saliva samples obtained on Day 7 after surgical removal of impacted mandibular third molar Day 7 after surgery
Secondary Evaluation of preoperative pain on visual analog scale Pain will be measured on a 10-cm long visual analog scale (VAS), where 0 means no pain at all, and 10 represent the greatest pain patients have ever felt. Higher scores on a scale mean worse outcome. 1 hour before surgery
Secondary Evaluation of postoperative pain on visual analog scale Pain will be measured on a 10-cm long visual analog scale (VAS), where 0 means no pain at all, and 10 represent the greatest pain patients have ever felt. Higher scores on a scale mean worse outcome. Hour 2 after surgery
Secondary Evaluation of postoperative pain on visual analog scale Pain will be measured on a 10-cm long visual analog scale (VAS), where 0 means no pain at all, and 10 represent the greatest pain patients have ever felt. Higher scores on a scale mean worse outcome. Hour 4 after surgery
Secondary Evaluation of postoperative pain on visual analog scale Pain will be measured on a 10-cm long visual analog scale (VAS), where 0 means no pain at all, and 10 represent the greatest pain patients have ever felt. Higher scores on a scale mean worse outcome. Hour 6 after surgery
Secondary Evaluation of postoperative pain on visual analog scale Pain will be measured on a 10-cm long visual analog scale (VAS), where 0 means no pain at all, and 10 represent the greatest pain patients have ever felt. Higher scores on a scale mean worse outcome. Hour 8 after surgery
Secondary Evaluation of postoperative pain on visual analog scale Pain will be measured on a 10-cm long visual analog scale (VAS), where 0 means no pain at all, and 10 represent the greatest pain patients have ever felt. Higher scores on a scale mean worse outcome. Hour 10 after surgery
Secondary Evaluation of postoperative pain on visual analog scale Pain will be measured on a 10-cm long visual analog scale (VAS), where 0 means no pain at all, and 10 represent the greatest pain patients have ever felt. Higher scores on a scale mean worse outcome. Hour 12 after surgery
Secondary Evaluation of postoperative pain on visual analog scale Pain will be measured on a 10-cm long visual analog scale (VAS), where 0 means no pain at all, and 10 represent the greatest pain patients have ever felt. Higher scores on a scale mean worse outcome. Hour 24 after surgery
Secondary Evaluation of postoperative pain on visual analog scale Pain will be measured on a 10-cm long visual analog scale (VAS), where 0 means no pain at all, and 10 represent the greatest pain patients have ever felt. Higher scores on a scale mean worse outcome. Hour 48 after surgery
Secondary Evaluation of postoperative pain on visual analog scale Pain will be measured on a 10-cm long visual analog scale (VAS), where 0 means no pain at all, and 10 represent the greatest pain patients have ever felt. Higher scores on a scale mean worse outcome. Hour 72 after surgery
Secondary Evaluation of postoperative pain on visual analog scale Pain will be measured on a 10-cm long visual analog scale (VAS), where 0 means no pain at all, and 10 represent the greatest pain patients have ever felt. Higher scores on a scale mean worse outcome. Day 7 after surgery
Secondary Evaluation of preoperative pain on verbal rating scale Pain will be measured on a 6-point verbal rating pain scale (VRS) where higher scores mean worse outcome (1-no pain; 2-mild pain; 3-moderate pain; 4-severe pain; 5-very severe pain; 6-the worst possible pain). 1 hour before surgery
Secondary Evaluation of postoperative pain on verbal rating scale Pain will be measured on a 6-point verbal rating pain scale (VRS) where higher scores mean worse outcome (1-no pain; 2-mild pain; 3-moderate pain; 4-severe pain; 5-very severe pain; 6-the worst possible pain). Hour 2 after surgery
Secondary Evaluation of postoperative pain on verbal rating scale Pain will be measured on a 6-point verbal rating pain scale (VRS) where higher scores mean worse outcome (1-no pain; 2-mild pain; 3-moderate pain; 4-severe pain; 5-very severe pain; 6-the worst possible pain). Hour 4 after surgery
Secondary Evaluation of postoperative pain on verbal rating scale Pain will be measured on a 6-point verbal rating pain scale (VRS) where higher scores mean worse outcome (1-no pain; 2-mild pain; 3-moderate pain; 4-severe pain; 5-very severe pain; 6-the worst possible pain). Hour 6 after surgery
Secondary Evaluation of postoperative pain on verbal rating scale Pain will be measured on a 6-point verbal rating pain scale (VRS) where higher scores mean worse outcome (1-no pain; 2-mild pain; 3-moderate pain; 4-severe pain; 5-very severe pain; 6-the worst possible pain). Hour 8 after surgery
Secondary Evaluation of postoperative pain on verbal rating scale Pain will be measured on a 6-point verbal rating pain scale (VRS) where higher scores mean worse outcome (1-no pain; 2-mild pain; 3-moderate pain; 4-severe pain; 5-very severe pain; 6-the worst possible pain). Hour 10 after surgery
Secondary Evaluation of postoperative pain on verbal rating scale Pain will be measured on a 6-point verbal rating pain scale (VRS) where higher scores mean worse outcome (1-no pain; 2-mild pain; 3-moderate pain; 4-severe pain; 5-very severe pain; 6-the worst possible pain). Hour 12 after surgery
Secondary Evaluation of postoperative pain on verbal rating scale Pain will be measured on a 6-point verbal rating pain scale (VRS) where higher scores mean worse outcome (1-no pain; 2-mild pain; 3-moderate pain; 4-severe pain; 5-very severe pain; 6-the worst possible pain). Hour 24 after surgery
Secondary Evaluation of postoperative pain on verbal rating scale Pain will be measured on a 6-point verbal rating pain scale (VRS) where higher scores mean worse outcome (1-no pain; 2-mild pain; 3-moderate pain; 4-severe pain; 5-very severe pain; 6-the worst possible pain). Hour 48 after surgery
Secondary Evaluation of postoperative pain on verbal rating scale Pain will be measured on a 6-point verbal rating pain scale (VRS) where higher scores mean worse outcome (1-no pain; 2-mild pain; 3-moderate pain; 4-severe pain; 5-very severe pain; 6-the worst possible pain). Hour 72 after surgery
Secondary Evaluation of postoperative pain on verbal rating scale Pain will be measured on a 6-point verbal rating pain scale (VRS) where higher scores mean worse outcome (1-no pain; 2-mild pain; 3-moderate pain; 4-severe pain; 5-very severe pain; 6-the worst possible pain). Day 7 after surgery
Secondary Evaluation of preoperative lobule-pogonion distance Baseline lobule-pogonion distance will be measured on the side requiring operation by means of a soft tape, and expressed in millimeters (mm). 1 hour before surgery
Secondary Evaluation of postoperative swelling Postoperative swelling will be assessed through measurement of lobule-pogonion distance on the operated side by means of a soft tape, and expressed in millimeters (mm). Hour 24 after surgery
Secondary Evaluation of postoperative swelling Postoperative swelling will be assessed through measurement of lobule-pogonion distance on the operated side by means of a soft tape, and expressed in millimeters (mm). Hour 48 after surgery
Secondary Evaluation of postoperative swelling Postoperative swelling will be assessed through measurement of lobule-pogonion distance on the operated side by means of a soft tape, and expressed in millimeters (mm). Day 7 after surgery
Secondary Evaluation of preoperative maximal inter-incisor distance Maximal inter-incisor distance at baseline will be measured by means of a soft tape, and expressed in millimeters (mm). 1 hour before surgery
Secondary Evaluation of postoperative trismus Trismus will be measured through assessment of a maximal inter-incisor distance by means of a soft tape, expressed in millimeters (mm). Hour 24 after surgery
Secondary Evaluation of postoperative trismus Trismus will be measured through assessment of a maximal inter-incisor distance by means of a soft tape, expressed in millimeters (mm). Hour 48 after surgery
Secondary Evaluation of postoperative trismus Trismus will be measured through assessment of a maximal inter-incisor distance by means of a soft tape, expressed in millimeters (mm). Day 7 after surgery
Secondary Patient satisfaction with the treatment Patient will mark their satisfaction with the treatment using 5-point Likert scale. The question that will be asked to the patients will be as follows: "How satisfied are you at this moment with the impacted mandibular third molar surgery?". Possible answers on the 5-point Likert scale would be: "5-very satisfied", "4-satisfied", "3-neutral", "2-dissatisfied", and "1-very dissatisfied". Higher scores mean better outcome. Hour 24 after surgery
Secondary Patient satisfaction with the treatment Patient will mark their satisfaction with the treatment using 5-point Likert scale. The question that will be asked to the patients will be as follows: "How satisfied are you at this moment with the impacted mandibular third molar surgery?". Possible answers on the 5-point Likert scale would be: "5-very satisfied", "4-satisfied", "3-neutral", "2-dissatisfied", and "1-very dissatisfied". Higher scores mean better outcome. Hour 48 after surgery
Secondary Patient satisfaction with the treatment Patient will mark their satisfaction with the treatment using 5-point Likert scale. The question that will be asked to the patients will be as follows: "How satisfied are you at this moment with the impacted mandibular third molar surgery?". Possible answers on the 5-point Likert scale would be: "5-very satisfied", "4-satisfied", "3-neutral", "2-dissatisfied", and "1-very dissatisfied". Higher scores mean better outcome. Day 7 after surgery
Secondary Rescue medication intake Patients will be instructed to note each rescue medication intake. At any time during 7 days of follow up
Secondary Day of rescue medication intake Patients will be instructed to note the day when each rescue medication has been taken. Options provided to the patients would be: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7. At any time during 7 days of follow up
Secondary Time of rescue medication intake in hours Patients will be instructed to note the time in hours (h) when each rescue medication has been taken. At any time during 7 days of follow up
Secondary Time of rescue medication intake in minutes Patients will be instructed to note the time in minutes (min) when each rescue medication has been taken. At any time during 7 days of follow up
Secondary Pain intensity on visual analog scale during each rescue medication intake Patients will be instructed to note pain intensity during each rescue medication intake on visual analog scale where 0 means no pain at all, and 10 represent the greatest pain patients have ever felt. Higher scores on a scale mean worse outcome. At any time during 7 days of follow up
Secondary Pain intensity on verbal rating scale during each rescue medication intake Patients will be instructed to note pain intensity during each rescue medication intake on a 6-point verbal rating pain scale (VRS) where higher scores mean worse outcome (1-no pain; 2-mild pain; 3-moderate pain; 4-severe pain; 5-very severe pain; 6-the worst possible pain). At any time during 7 days of follow up
Secondary Dosage of each rescue medication intake Patients will be instructed to note the dosage of each rescue medication used. At any time during 7 days of follow up
Secondary Incidence of adverse events Patients will be instructed to write any postoperative adverse event if occurs At any time during 7 days of follow up
See also
  Status Clinical Trial Phase
Completed NCT05619796 - Assessment of Clinical & Radiographic Efficiency of Manual & Pediatric Rotary Systems in Primary Root Canal Preparation N/A
Recruiting NCT05338671 - Effect of Post-Operative Anesthetics on Post-Operative Pain in Patients Receiving Endodontic Treatment Phase 4
Completed NCT05584696 - Effectiveness of Green Color Exposure on Dental Anxiety N/A
Completed NCT05593341 - Opioid Education in Total Knee Arthroplasty N/A
Not yet recruiting NCT05255146 - Cryoanalgesia and Post-thoracotomy Pain in Minimally Invasive Cardiothoracic Surgery N/A
Not yet recruiting NCT06020196 - The Safety and Efficacy of Surgical Rectus Sheath Block for Postoperative Analgesia After Elective Cesarean Delivery N/A
Completed NCT01697748 - Prospective Study on Cesarean Wound Outcomes N/A
Completed NCT01681966 - A Single-dose Open-Label Study to Assess the Safety and Preliminary Efficacy of PRF 110 in Open Herniorrhaphy Surgery Phase 2
Completed NCT01442818 - Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery N/A
Completed NCT00625911 - Ketamine Improves Post-Thoracotomy Analgesia N/A
Terminated NCT05494125 - Effects of Continuous ESP Catheters on Recovery, Pain and Opioid Consumption After Multilevel Spine Surgery N/A
Recruiting NCT04767399 - Comparison of Postoperative Pain After Instrumentation in Different Visits With Different Single File Systems. N/A
Not yet recruiting NCT05863624 - Open and Endoscopic Technique in Female Inguinal Hernia Repair. FemaleHernia N/A
Completed NCT06048744 - Ultrasound Guided Erector Spinae Plane Block vs External Oblique Intercostal Plane Block for Nephrectomy N/A
Active, not recruiting NCT05374499 - Double-Blinded Randomized Controlled Study Investigating the Efficacy of Exparel (Liposomal Bupivacaine) for Postoperative Pain Relief in Mandibular Third Molar Extractions Phase 4
Completed NCT05510947 - Acute Postoperative Pain and Catastrophizing in Patients Undergoing Unicompartmental Knee Arthroplasty
Completed NCT06065683 - Acute Postoperative Pain Prevalence and Intensity in the First 72 Hours
Completed NCT05552391 - Dexametomedine Versus Ketamine as an Adjuvant in Erector Spinae Block for Perioperative Thoracotomy Pain Control Phase 4
Completed NCT06082479 - The Effect of Intra Oral Cryotherapy in Patients With Symptomatic Apical Periodontitis N/A
Recruiting NCT04909060 - Does the Newborn Infant Parasympathetic Evaluation (NIPE) Index Predict Postsurgical Pain in Children