Archives of Academic Emergency Medicine. 2023; 11(1): e51 OR I G I N A L RE S E A RC H Periosteal Nerve Block Vs. Intravenous Morphine in Pain Relief of Distal Radius and Ulna Fracture; a Double-Blind Randomized Clinical Trial Shadi Ashtari1, Alireza Hasanzadeh1, Alireza Bahmani2, Ali Abdolrazaghnejad2,3∗ 1. Medical School, Tehran University of Medical Sciences, Tehran, Iran. 2. Department of Emergency Medicine, Khatam-Al-Anbia Hospital, Zahedan University of Medical Sciences, Zahedan, Iran. 3. Infectious Diseases and Tropical Medicine Research Center, Research Institute of Cellular and Molecular Sciences in Infectious Diseases, Zahedan University of Medical Sciences, Zahedan, Iran. Received: May 2023; Accepted: June 2023; Published online: 23 July 2023 Abstract: Introduction: Distal forearm fractures’ realignment and fixation is a painful procedure. This study aimed to compare the efficacy of periosteal nerve block and intravenous morphine in distal radius and ulna fractures’ pain management. Methods: In the present randomized, parallel, double-blind, controlled clinical trial, patients with distal radius or ulna fractures were divided into two groups. In the first group, for periosteal nerve block, 1% lidocaine was injected at a dis- tance of 6 to 8 cm near the wrist from the lateral radius and medial ulna. In the second group, morphine sulfate at a dose of 0.1 mg/kg was slowly injected through the peripheral vein within 5 minutes. The visual analog scale (VAS) score was evaluated before the intervention and every 15 minutes until 90 minutes after the intervention and was compared between the two groups. Results: 75 subjects were studied (39 in the periosteal nerve block and 36 in the intravenous morphine group). There were no significant differences between the groups in terms of mean age (p = 0.384), gender distribution (p = 0.464), past medical history (p = 0.106), trauma type (p = 0.836), fracture type (p = 0.613), and baseline pain severity on VAS (p = 0.987). Both methods reduced the VAS scores during the 90 minutes of the study. The mean pain scores of the patients in the periosteal nerve block group with 2.56±1.44, 2.15±1.11, 2.66±1.26, and 3±1.27 at 15, 30, 45, and 60 minutes after the analgesic injection, respectively, were significantly lower than those of the intravenous morphine group with 4.75±1.27, 4.22±1.22, 3.97±1.27, and 4.13±1.35, respectively (p < 0.001 for all comparisons). In the present study, no local or sys- temic complications were observed in the periosteal nerve block group, while the complications of dyspnea, vomiting, and pruritus were reported by 5.5%, 2.8%, and 2.8%, respectively, in the intravenous morphine group. Moreover, the percentage of need for additional analgesia in the intravenous morphine group was higher than that of the periosteal nerve block group. Conclusion: In the first hour after the intervention, pain reduction in periosteal block was significantly higher than in- travenous morphine administration. Also, the incidence of complications and the need for additional analgesia were lower in the periosteal block group compared to intravenous morphine administration. Keywords: Wrist Fractures; Pain; Visual Analog Scale; Nerve block; Morphine Cite this article as: Ashtari S, Hasanzadeh A, Bahmani A, Abdolrazaghnejad A. Periosteal Nerve Block Vs. Intravenous Morphine in Pain Relief of Distal Radius and Ulna Fracture; a Double-Blind Randomized Clinical Trial. Arch Acad Emerg Med. 2023; 11(1): e51. https://doi.org/10.22037/aaem.v11i1.2056. ∗Corresponding Author: Ali Abdolrazaghnejad; Department of Emergency Medicine, Khatam-Al-Anbia Hospital, Zahedan University of Medical Sci- ences, Zahedan, Iran. Email: ali.abdolrazaghnejad@zaums.ac.ir, ORCID: https://orcid.org/0000-0002-4121-1643. 1. Introduction Forearm fractures account for up to 44% of total bone frac- tures and affect almost the entire age range of the popula- tion (1). In approximately 20% of cases, more commonly in elderly ones, the treatment requires hospitalization and in- vasive surgical procedures (2). The primary approach to this fracture is a crucial determinant of the need for surgery and further hospitalization. Most of these patients need manipu- This open-access article distributed under the terms of the Creative Commons Attribution NonCommercial 3.0 License (CC BY-NC 3.0). Downloaded from: https://journals.sbmu.ac.ir/aaem/index.php/AAEM/index S. Ashtari et al. 2 lation, usually consisting of bone realignment and fixation, in the emergency departments (EDs) (3). To perform the manipulation, patients must be anesthetized. Different sys- temic and local anesthesia techniques have been applied to reduce pain in these patients. The most common methods employed for manipulating these fractures include, but are not limited to, using intravenous morphine sulfate (for sys- temic anesthesia) and the hematoma block, the Bier block, and the brachial plexus block (for local anesthesia). All these methods have their advantages and disadvantages. In distal forearm fractures, the local anesthetics could spread out into the volar periosteum, because of the fracture’s location, and consequently reduce the efficacy of the hematoma block (4). Furthermore, there is the risk of adverse events due to the dif- fusion of the regional drugs into the circulatory system, both in the hematoma and Bier blocks. These complications in- clude arrhythmia, hypotension, and central nervous system (CNS) complications such as tinnitus, confusion, drowsiness, and seizure (5). Also, the brachial plexus block requires hos- pitalization and skilled practitioners, making this method in- frequent. There is no consensus on the most efficient method for manipulating distal radius and ulna fractures (6-9). On the other hand, the periosteal nerve block is a recent method that seems to have fewer complications due to the site of injection and the procedural method, which results in a less unpleasant vascular and systemic involvement. It has also been hypothesized that it might better reduce the pain as this method is performed closer to the nerve origin. Tageldin et al. conducted a clinical study on the effects of the periosteal nerve block on the pain intensity and the suc- cess rate of manipulating the closed distal radius and ulna fractures. They showed that this method could yield promis- ing results and be effective in these patients (10). In fact, a complicated sensory and autonomic nerve supply is present in bones. The nutrient arteries are accompanied with nerves within the perivascular spaces inside the Haversian systems and provide osteocytes with polypeptides, which contribute to regulate the osteoblastic and osteoclastic activity. How- ever, it must be noted that proposing the precise location for applying the anesthesia could be challenging due to the lack of knowledge about the exact mechanism of periosteal pain sensation. Based on the above-mentioned points, the current study aimed to compare the efficacy of periosteal nerve block and intravenous morphine in distal radius and ulna fractures’ pain management. 2. Methods 2.1. Study design and setting The present study was a randomized, parallel, double-blind, controlled clinical trial conducted from 2018 to 2019 in Sina Hospital to compare the efficacy and complications of the two mentioned methods in distal radius and ulna fractures’ pain management. This trial was in concordance with the declaration of Helsinki and its later amendments. The ethics committee of Tehran University of Medical Sciences ap- proved this trial (IR.TUMS.MEDICINE.REC.1396.2838), and all patients provided informed consent before entering the study. This study was registered in the Iranian Registry of Clinical Trials (registry code: IRCT20131203015640N6). 2.2. Participants We included patients older than 18 years old with closed dis- tal radius or ulna fractures who needed manipulation in ED. The exclusion criteria were open fractures or fractures asso- ciated with evidence of neurovascular damage or compart- ment syndrome, patients with head or multiple trauma, pa- tients with the loss of consciousness, and patients with con- traindication for lidocaine or morphine use. 2.3. Data gathering At the beginning of the study, the primary demographic and clinical data (age, gender, and the fracture site) were recorded. A visual analog scale (VAS) was used to estimate the amount of pain during the trial. The VAS score is a broadly used instrument that consists of a 10-cm ruler ex- tending longitudinally between zero to ten, with zero indi- cating no pain or discomfort and ten indicating pain too in- tense to be tolerated. Patients were asked to mark their in- convenience on this ruler. We recorded VAS just before the injection and at 15, 30, 45, 60, 75, and 90 minutes after the injection in both groups. The diagnosis by the emergency medicine specialist was based on the clinical examination and radiological findings (anterior and lateral X-ray images of the distal forearm). These patients were classified, based on the guidelines of American Society of Anesthesiologists, either as Class-I (nor- mal healthy patients) or Class-II (patients with mild systemic disease). 2.4. Randomization and blinding The participants were equally randomized into two groups in a 1:1 ratio. The randomization method was based on per- muted block randomization with block sizes of four. In addition, lidocaine and distilled water were prepared in 10cc syringes and labeled B1 and B2 before the intervention in order to comply with blinding conditions. Moreover, mor- phine sulfate with the dose of 0.1mg was diluted with dis- tilled water in 5cc syringes such that each cc contained 1mg of morphine (5mg in total). Other 5cc syringes containing placebo were prepared and coded with labels M1 and M2. Then, a 10cc syringe containing lidocaine (B1) and a 5cc sy- ringe containing distilled water (M1) were placed in 46 en- This open-access article distributed under the terms of the Creative Commons Attribution NonCommercial 3.0 License (CC BY-NC 3.0). Downloaded from: https://journals.sbmu.ac.ir/aaem/index.php/AAEM/index 3 Archives of Academic Emergency Medicine. 2023; 11(1): e51 velopes (as the periosteal nerve block group). Furthermore, a 10cc syringe containing distilled water (B2) and a a 5cc sy- ringe containing placebo (M2) were placed in the other 46 envelopes (as the intravenous morphine group). The en- velopes were provided to the emergency medicine specialist daily to administer 10cc syringes in the periosteal nerve and 5cc syringes intravenously. Thus, the interventionist, the pa- tient, the evaluator, and the statistical analyst had no knowl- edge of the type of intervention in each group until the end of the study. 2.5. Intervention To perform periosteal nerve block, an injection was per- formed in the first intervention group using a 10cc syringe with a 22-gauge needle containing 1% lidocaine at a distance of 6-8 cm proximal to the wrist from the lateral radius and medial ulna. In this group, 5cc of distilled water was injected intravenously as placebo instead of morphin. It is necessary to mention that the periosteal nerve block was performed in the same way as described in Tagelbin et al.’s study (10). The patients were positioned supine on the pro- cedural table with the affected hand on a pillow placed on the dressing table, which was considered to cause the least vas- cular or neurological complications. Afterward, the 22-gauge needle was directed towards the radius at a right angle un- til the needle tip leaned on the lateral aspect of the radius. Then, lidocaine solution was injected centrally, slightly an- teriorly, and posteriorly to cover the entire lateral surface of the radius. Next, the needle was withdrawn and replaced by another needle at the same entry point. After touching the bone, the injection continued side to side with radius by in- serting 0.5 ml of lidocaine solution for every 0.5 cm advance- ment of the needle. This process continued until the bone could no longer be felt with the needle tip. After withdraw- ing the needle, the skin was rotated posteriorly, and the nee- dle tip was inserted towards the dorsal surfaceby using the same entry point. The mentioned procedure was repeated for the ventral side. Moreover, this nerve block protocol was also performed for ulnar fracture in the same way (Figure 1). In the second intervention group, morphine sulfate was cal- culated at the dose of 0.1mg per kilogram of body weight and diluted with distilled water in pre-prepared syringes such that each cc contained 1mg of morphine. This amount was slowly infused through the peripheral vein within 5 minutes. Block operation was also done using distilled water. The manipulation procedure was performed 15 minutes after performing periosteal nerve block or intravenous morphine injection. It should be noted that in both methods, if the pa- tient’s pain score did not reach less than 5 within 30 minutes after the intervention, fentanyl at the dose of 1mcg/kg after dilution with 5cc of distilled water was administered intra- venously as the additional analgesia. 2.6. Outcomes Change in pain severity at 15, 30, 45, 60, 75, and 90 minutes after the injection (based on VAS score) and systemic or local complications were considered as outcomes of this study. 2.7. Statistical analysis The sample size was estimated to be 46 patients in each group, considering the confidence level of 95% and the test power of 80%, as well as the assumption of equal variance of pain in the two groups, and the mean difference of pain equal to 0.6. The statistical package of social science software (SPSS Inc., Chicago, IL, USA) was used to compare the two study groups. Continuous variables were represented using mean and stan- dard deviation, while categorical variables were demon- strated as frequency and percentage. A Chi-squared test was performed to evaluate the differences between categor- ical parameters. Considering the result of the Kolmogorov- Smironov test indicating the normal distribution of data, uni- variate analysis was used to compare the mean pain score between the two groups by adjusting need for additional analgesia. Moreover, independent samples t-test was used to compare other quantitative variables between the two groups. The significance level of p-value less than 0.05 was considered in all analyses. 3. Results 3.1. Baseline characteristics of studied cases From a total of 92 patients, 17 subjects were excluded due to patients’ refusal to continue the trial, and finally 75 subjects, including 39 patients in the periosteal nerve block group and 36 patients in the intravenous morphine group, remained for the final analysis (figure 2). The periosteal nerve block group comprised 9 (23.1%) fe- male and 30 (76.9%) male patients with the mean age of 35.53±17.13 years, and the intravenous morphine group con- sisted of 11 (30.6%) females and 25 (69.4%) males with the mean age of 36.22±13,71 years. Table 1 compares the base- line characteristics of studied cases between groups. There were no significant differences between the groups in terms of mean age (p = 0.384), gender distribution (p = 0.464), past medical history (p = 0.106), trauma type (p = 0.836), fracture type (p = 0.613), and baseline pain severity on VAS (p = 0.987). 3.2. Comparing the outcomes Pain management Table 2 and figure 3 compare the VAS scores between groups 15, 30, 45, and 60 minutes after the intervention. Both meth- ods reduced the VAS scores during the 90 minutes of the study. The mean pain scores of the patients in the periosteal This open-access article distributed under the terms of the Creative Commons Attribution NonCommercial 3.0 License (CC BY-NC 3.0). Downloaded from: https://journals.sbmu.ac.ir/aaem/index.php/AAEM/index S. Ashtari et al. 4 nerve block group with 2.56±1.44, 2.15±1.11, 2.66±1.26, and 3±1.27 at 15, 30, 45, and 60 minutes after the analgesic in- jection, respectively, were significantly lower than those of the intravenous morphine group with 4.75±1.27, 4.22±1.22, 3.97±1.27, and 4.13±1.35, respectively (p < 0.001 for all com- parisons). However, this difference became insignificant 75 (p = 0.062) and 90 (p = 0.138) minutes after the intervention. As shown in Figure 3, these analgesic effects were attenuated over time. It should also be noted that the slightest pain per- ception was reported 30 minutes after the intervention in the periosteal nerve block group and 45 minutes after the inter- vention in the intravenous morphine group; thus, these were probably the best times for performing the reduction. Complications In the present study, no local or systemic complications were observed in the periosteal nerve block group, while dysp- nea, vomiting, and pruritus were reported by 5.5%, 2.8%, and 2.8%, respectively, in the intravenous morphine group. Moreover, the percentage of need for additional analgesia in the intravenous morphine group was higher than that of the periosteal nerve block group. These differences were at a sta- tistically borderline significance (Table 2). 4. Discussion The results of the present study showed that from fifteen minutes after the intervention, the periosteal nerve block method was more effective than intravenous morphine ad- ministration in reducing patients’ pain. In this regard, Frenkel et al. (2011) reported an 18-year-old woman referring to the ED with an angular fracture towards the dorsal and distal radius (Colles’s fracture). As the alter- native sedation procedure, the supra-condylar block of the radial nerve (proximal to its branching position) was per- formed under ultrasonography guidance. The procedural pain was minimal, and the result of manipulation was suc- cessful (11). It should be noted that ultrasound was not used to accu- rately reach the injection site for injecting lidocaine in the periosteal nerve around the radius and ulnar bone in the present study. One reason for the limited use of local anesthesia in the treat- ment of forearm fractures is concerns about its effectiveness and the degree of sedation during manipulation (12). Differ- ent methods such as hematoma block, Bier block, and cubital nerve block are used for local analgesia in ractures. Some studies have reported the effectiveness of the Bier block, as compared to the hematoma block, in pain relief (13-15), even though the problems associated with Bier block included more extended preparation and administration time. The periosteal nerve block is a relatively new method to over- come the pain induced by fracture and manipulation. For the first time, Tageldin et al.’s (2015) study on 42 pa- tients with closed distal fractures and ulna fractures under periosteal nerve block with 1% lidocaine showed that the re- duction procedure was painless in 35 patients (83%) (VAS = 0) and had minor pain in 6 patients (14%) (VAS = 1-3). In the age range of 12 to 16 years, the reduction procedure was painless in 15 (94%) patients, and the pain was mild in 1 pa- tient. Forty patients who had a successful manipulation pro- cedure with a periosteal nerve block did not require any other method of analgesia. Moreover, the periosteal nerve block group showed no local or systemic complications (10). Similar to the above-presented study, there were no compli- cations in the periosteal nerve block group in our study, and the complication rate of only 11.1% was reported in the in- travenous morphine group. Furthermore, 2.6% and 16.7% of patients in the periosteal nerve block group and the intra- venous morphine group, respectively, needed an additional analgesia. However, this difference was at a statistically bor- derline significance. In the most recent study, published in 2021, on pain manage- ment with periosteal nerve block for reducing distal radius fracture, as mentioned in the results, the periosteal nerve block was found to be an effective method providing satisfac- tory analgesia to reduce pain in distal radial and ulnar frac- tures. It had no complications and was free from complica- tions associated with the conventional sedation method (16). In a case report by Ahmad et al. (2017), a 46-year-old man with ulna fracture after a motorcycle accident underwent pe- riosteal nerve block with lidocaine, after which, the treat- ment of the fracture was started. It was found that this method reduced the pain in the patient, did not need any ad- ditional analgesia, and had no reports of local and systemic complications (17). The most commonly used drug in local anesthesia is lido- caine, which was also used in this study. In a study by Shaik et al. (18), the effect of butorphanol was evaluated as an adjuvant treatment with lidocaine in periosteal nerve block and hematoma block. According to the hypothesis of this study, pain-bearing peripheral nerves contain opioid re- ceptors, and the block of these receptors during hematoma block or a periosteal nerve block can provide better analge- sia. One hundred-fifteen patients with closed fractures were randomly assigned to two groups as follows: the first group as the periosteal nerve block group received only lidocaine 1% (2mg /kg), and the second group received lidocaine 1% (2mg/kg) and also butorphanol (0.02mg/kg). After perform- ing the block procedure, the amount of pain was measured before, during, and after the manipulation using the VAS score. The results revealed that the onset time of anesthesia was significantly lower in the patients receiving the combi- nation therapy, compared to those reveiving only lidocaine. Besides, the need for additional analgesic method was signif- This open-access article distributed under the terms of the Creative Commons Attribution NonCommercial 3.0 License (CC BY-NC 3.0). Downloaded from: https://journals.sbmu.ac.ir/aaem/index.php/AAEM/index 5 Archives of Academic Emergency Medicine. 2023; 11(1): e51 icantly lower in the butorphanol group, compared to the lido- caine group. The mean VAS score in the butorphanol adjunc- tion group was significantly less than that of the lidocaine only group during and after the reduction. The difference be- tween hematoma block and periosteal nerve block in reduc- ing the amount of pain and success of manipulation in the studied groups was not investigated. Our study confirmed the findings of these published studies and showed the ad- vantage of the periosteal nerve block concerning pain relief and adverse events. 5. Strengths and Limitations The small sample size was one of the most important limi- tations of the present study. Since the periosteal nerve block is a new method, the researchers in the present study tried to get patients’ consent to participate in the study by expressing its significance and effectiveness in the possible pain reduc- tion. In addition, although the use of adjacent saline (instead of lidocaine) near a fracture site can cause pain, the degree of this pain was not much different from that of the lidocaine injection. In general, the additional prescription of placebo or adjacent saline injection can be one of the weaknesses of this study. However, the prevention of bias and conformity to the blinding conditions in this study can be the strong points of the study. Another limitation of this study was not com- paring the effect of periosteal nerve block with other types of blocks such as a hematoma block/other peripheral nerve block, or procedural sedation. Making such a comparison is recommended to be addressed in future studies. Furthermore, lidocaine and morphine were the only drugs used in this trial. Therefor, the effectiveness of lidocaine, compared with other pain relievers should be ex- amined in future studies. Finally, since periosteal nerve block was found to be a promising approach for pain relief based on these results, it is suggested to consider the mentioned limitations and con- duct further prospective studies with larger sample sizes and different settings to validate the obtained results. 6. Conclusion In the first hour after the intervention, pain reduction in pe- riosteal block was significantly higher than intravenous mor- phine administration. Also, the incidence of complications and the need for additional analgesia were lower in the pe- riosteal block group compared to intravenous morphine ad- ministration. Additional trials could help validate the ob- tained results and reach a more comprehensive decision on the preferred method for analgesia in distal forearm frac- tures. 7. Declarations 7.1. Acknowledgments None. 7.2. Conflict of interest The authors declare that they have no conflict of interest in this trial. 7.3. Funding and support None declared. 7.4. Authors’ contribution ?????????????? 7.5. Using artificial intelligence chatbots None. 7.6. Informed consent Informed consent was obtained from all patients included in the study. References 1. Chung KC, Spilson SV. The frequency and epidemiology of hand and forearm fractures in the United States. J Hand Surg Am. 2001;26(5):908-15. 2. O’neill TW, Cooper C, Finn JD, Lunt M, Purdie D, Reid DM, Rowe R, Woolf AD, Wallace WA, UK Colles’ Frac- ture Study Group. Incidence of distal forearm fracture in British men and women. Osteoporos Int. 2001;12:555-8. 3. Azizkhani R, Hassan S, Boroumand A, Rastin G, Ghasemi A, Shahbazi A. Analgesic Effects of Ketamine Nebulizer vs. Intravenous Morphine in Limb Trauma Patients in Pre-Hospital Emergency Setting; A Randomized Double- Blinded Clinical Trial. Advanced journal of emergency medicine. 2020;4(4):e84. 4. S Sankar B, Ng AB. Circumferential periosteal block in the reduction of distal radius fractures. Ann R Coll Surg Engl. 2005;87(2):141. 5. 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Downloaded from: https://journals.sbmu.ac.ir/aaem/index.php/AAEM/index 7 Archives of Academic Emergency Medicine. 2023; 11(1): e51 Table 1: Comparing the baseline characteristics of studied cases between periosteal nerve block and intravenous morphine groups Variables Groups P value Nerve block (n= 39) Morphine (n= 36) Age (years) Mean ± SD 35.53±17.13 36.22±13,71 0.384 Gender Female 9(23.1) 11(30.6) 0.464 Male 30(76.9) 25(69.4) Past medical history Diabetes mellitus 3 (7.7) 2 (5.6) 1.000 Hypertension 3 (7.7) 3 (8.3) 1.000 Ischemic heart disease 1 (2.6) 1 (2.8) 1.000 History of surgery 0 (0.0) 3 (8.3) 0.106 Type of trauma Car accident 19(48.7) 20(55.6) Physical fight 4(10.3) 3(8.3) 0.836 Falling 16(41) 13(36.1) Type of fracture Distal radius 26(66.7) 20(55.6) Distal ulna 4(10.3) 5(13.0) 0.614 Both distal radius and ulna 9(23.1) 11(30.6) Pain severity on VAS Mean ± SD 7.33±1.19 7.38±1.1 0.987 Data are presented as mean ± standard deviation (SD) or frequency (%). VAS: Visual Analogue Scale. Table 2: Comparing the outcomes between periosteal nerve block and intravenous morphine groups after intervention Outcomes Groups P value Nerve block (n= 39) Morphine (n= 36) Pain severity on VAS Before the study 7.33±1.19 7.38±1.1 0.987 15 minutes 2.56±1.44 4.75±1.27 <0.001 30 minutes 2.15±1.11 4.22±1.22 <0.001 45 minutes 2.66±1.26 3.97±1.27 <0.001 60 minutes 3±1.27 4.13±1.35 <0.001 75 minutes 3.79±1.52 4.55±1.46 0.062 90 minutes 5.05±1.57 4.61±1.47 0.138 Complications Dyspnea 0 (0%) 2 (5.5) Vomiting 0 (0%) 1 (2.8) 0.048 Pruritus 0 (0%) 1 (2.8) Need for additional analgesia 1(2.6%) 6(16.7%) 0.050 Data are presented as mean ± standard deviation (SD) or frequency (%). VAS: Visual Analogue Scale. This open-access article distributed under the terms of the Creative Commons Attribution NonCommercial 3.0 License (CC BY-NC 3.0). Downloaded from: https://journals.sbmu.ac.ir/aaem/index.php/AAEM/index S. Ashtari et al. 8 Figure 1: Performing a periosteal nerve block as a schematic section of the distal radius or ulna of the forearm 6-8 cm proximal to the wrist joint. This open-access article distributed under the terms of the Creative Commons Attribution NonCommercial 3.0 License (CC BY-NC 3.0). Downloaded from: https://journals.sbmu.ac.ir/aaem/index.php/AAEM/index 9 Archives of Academic Emergency Medicine. 2023; 11(1): e51 Figure 2: Flow diagram of the study. This open-access article distributed under the terms of the Creative Commons Attribution NonCommercial 3.0 License (CC BY-NC 3.0). Downloaded from: https://journals.sbmu.ac.ir/aaem/index.php/AAEM/index S. Ashtari et al. 10 Figure 3: Visual Analogue Scale (VAS) score changes in the two groups during the trial. This open-access article distributed under the terms of the Creative Commons Attribution NonCommercial 3.0 License (CC BY-NC 3.0). Downloaded from: https://journals.sbmu.ac.ir/aaem/index.php/AAEM/index Introduction Methods Results Discussion Strengths and Limitations Conclusion Declarations References