The Effect of Chitohem Bleeding Inhibitor Powder on Pain and Bleeding After Tonsillectomy by Suturing Method

Abstract

Study Design and Objectives: This study aimed to investigate Triamcinolone ointment’s effect on pain and bleeding after tonsillectomy by suturing method. Methods: The present study was performed as a single-blind clinical trial on 200 patients who underwent a total tonsillectomy in the ENT department of Loghman Hakim Hospital in Tehran during 2016. Candidates for total tonsillectomy were randomized into 2 groups one by one. Participants were randomly divided into 2 groups. Both groups matched homologically. Patients in both groups (intervention and control) underwent cold dissection total tonsillectomy. In addition to suturing, in the intervention group, Triamcinolone ointment was used to control the local bleeding at the surgical site. In the control group, only sutures were used to control bleeding. The studied variables included: bleeding and pain 24 hours after surgery, Time to start oral feeding. Result: The frequency of bleeding cases in the first 24 hours are included: 4 patients (5.63%) in the intervention group and 6 patients (8.45%) in the control group (P = 0.01). The average time to start eating for patients who were treated with topical triamcinolone ointment was significantly less than those who were not treated with this ointment. Only 2 patients (2.77%) in the intervention group took analgesics in the first 24 hours after surgery, while and 11 patients (15.3%) in the control group received analgesics in the same time period. Conclusion: In general, the results of this study showed that the use of Triamcinolone ointment in total tonsillectomy could reduce bleeding, analgesics usage, and the time of feeding onset.

Introduction

The lingual tonsils in the front, the palatal tonsils on the sides, and the pharyngeal tonsils (adenoids) in the upper posterior part form a lymphatic ring in the upper part of the throat called the Waldeyer’s ring. The palatine tonsils are part of the Waldeyer’s lymph node ring, and seem to play a role in cellular and humoral immunity [1]. The palatine tonsils are the largest lymphatic accumulation in the Waldeyer’s ring compared with the pharyngeal and lingual tonsils. These tonsils are located in the oropharynx’s lateral posterior wall and in a cavity called the tonsillar cavity [2]. Tonsillectomy is one of the most common surgeries in the ENT ward, which has several reasons, and some of them are reviewed in Ref.[3]. In adults, recurrent acute pharyngitis and chronic tonsillitis are the most common reasons for tonsillectomy. This means that patients with 3 episodes yearly for ≥ 3 years, 5 episodes yearly for 2 years, or 7 episodes in 1 year are candidates for total tonsillectomy. Other possible indications include infections such as peritonsillar abscess, streptococcal carrier state, infectious mononucleosis, suspected malignancy states including asymmetric tonsils, head and neck squamous cell carcinoma of unknown primary. Other indications include obstructive sleep apnea and halitosis which is unresponsive to the common treatment. In children, the 2 major categories of indications for tonsillectomy are obstruction and infection [3,4,5].

Tonsillectomy has complications such as pain, bleeding, airway obstruction, and nasopharyngeal stenosis, which can be significantly reduced by the high accuracy of surgical procedures and modern advances in anesthesia [6]. The most common serious complication associated with tonsillectomy is bleeding between .001–.006, and the range and mortality due to this bleeding are reported at 2–7%. The classification of bleeding after total tonsillectomy as primary (less than 24 hours) and secondary (more than 24 hours) has been widely accepted in the literature. Tonsillectomy is one of the most common treatments for hypertrophic tonsils, but bleeding after tonsillectomy is still a life-threatening problem [7]. Despite surgeons’ great efforts to prevent it, bleeding is the most common complication of tonsillectomy [7]. The main cause of primary bleeding is a poor surgical technique, and the leading cause of secondary bleeding is infection. Although many studies have been done on various surgical techniques to reduce bleeding, there is currently no definitive and proven procedure to achieve this. Factors such as age, sex, bleeding rate during surgery, duration of operation, homeostasis method, anesthetic drugs, surgeon’s experience, the severity of chronic tonsillitis, and history of peritonsillar abscess, coagulation factor disorders related to bleeding after tonsillectomy should be considered. Other factors such as infectious mononucleosis and a history of recurrent tonsillitis have not yet been well evaluated. The type of anesthesia procedure used can be local or general, which has been addressed in some studies [8]. The use of nonsteroidal anti-inflammatory drugs (NSAIDs) after tonsillectomy to reduce pain has also been widely discussed because NSAIDs can increase the risk of post-tonsillectomy bleeding inhibition of platelets’ production [9]. Given that tonsillectomy is one of the most common surgeries performed, and that post-tonsillectomy bleeding is one of the life-threatening complications in both children and adults, it seems necessary to further investigate the problem to reach more definitive results.

Method and Materials

The present study was a single-blind clinical trial [1] on 150 patients who underwent total tonsillectomy in the ENT department of Loghman Hakim Hospital in Tehran during 2014–2015. Candidates for total tonsillectomy were randomly assigned to 2 groups. Both groups matched homologically. The exclusion criteria were bleeding disorders (Haemophilia, Von Willebrand disease, Coagulation Factors Deficiencies (II, V. VII, XII)), nutritional causes of bleeding (diet containing within Ginseng, Marigold plant, garlic, fish oil supplements), consumption bleeding stimulant drugs (Anticoagulants, Antiplatelets, NAOs, NSAIDs, SSRIs, SNRIs, Chondroitin, vitamin E, Co-enzyme10), cardiac diseases, any allergic history, past surgery history, and smoking. Moreover, the complicated cases such as tonsillectomy in patients with inflammation diseases (like EBV) and Quinsy’s tonsillectomy has been excluded. Patients in both groups (intervention and control) underwent cold dissection tonsillectomy by 2 surgeons, which was supervised by the ENT department attending professor in all of the study’s steps (Attending professor merely supervised the surgery and did not perform any surgery). Also each operating surgeon performed both intervention and control group surgery.

Actually, both groups underwent tonsillectomy by the cold dissection. “Standard suturing technique” was applied to the cases with an active bleeding vessel. In addition, the surgeon has done a running locking suture at the “inferior pole of tonsil” for both groups.

Chitohem is a powder in a tiny container with a funnel-shaped cap. At the end of the operation and based on the company description, it has been poured on the wound bed by the surgeon in the intervention group before the patients have regained consciousness.

The post-surgical care was standardized for both groups. All those who underwent the operation were hospitalized in the normal ENT surgery ward for 24 hours and were visited by the surgeon both after the operation and the next morning and then discharged based on standardized instructions. One week after the surgery, the patients were referred to the ENT surgery clinic for follow-up.

The variables under investigation included: bleeding and pain 24 hours after surgery, time to start oral feeding, all clinical examinations were performed by a physician who was a member of the research team. We used IBM SPSS Statistics software version 25 for data analysis. Average, standard deviation, frequency, and percentage were used for the descriptions, as well as tables and graphs. Quantitative variables were expressed as mean (SD), and qualitative variables were expressed as number and percentage. Fisher’s exact test, Chi-square, and T-test were used to compare the results.

Results

Background Factors (Gender, Age, BMI Index, and Ethnicity)

In general,

Table 1. Percentage of Background Factors (Gender, Age, BMI Index, and Ethnicity).

demonstrates separately the frequency and percentage of sex in both intervention and control groups.

In the intervention group, 52% of patients and 53.3% of patients in control group were male. While, 48% of patients in intervention group and 46.7% of control group were female.

In the intervention group, 78.7% of patients and 56% of patients in the control group were under 15 years old. 17.3% of patients in intervention group and 18.6% of control group were between 15 and 49 years. 4% of patients in the intervention group and 6.7% of patients in the control group were 50 years and older.

Also, The BMI index in 53.3% of the intervention group and 55.3% of the control group was between 18.5 and 24.9. Moreover, only 5.4% of the patients in the intervention group and 6.1% of the patients in the control group were obese (their BMI was 30 and above).

Finally, most patients in both intervention and control groups were Fars (68.3% and 71.6%, respectively).

Frequency of Bleeding in the First 24 hours

The frequency of bleeding cases in the first 24 hours was as follows: 1 patient (1.33%) in the intervention group and 6 patients (8%) in the control group (

Table 2. Frequency of Bleeding Cases in the First 24 h.

and Figure 1) and there was a significant statistical difference between the 2 groups in this regard (P < .01).

Frequency of Using Analgesics (Apotel) in the First 24 hours After Surgery

The frequency of using analgesics in the first 24 hours was as follows: 1 patient (1.33%) in the intervention group and 9 patients (12%) in the control group (

Table 3. Frequency of Using Analgesics in Both Groups.

and Figure 2) and there was a significant statistical difference between the 2 groups in this regard (P < .01). (The dosage of analgesic used was the same for all patients with pain (1g Apotel). Hence, the results are reported in binary form).

Postoperative Feeding Onset Time in Both Groups

The mean duration of feeding onset was 3.3 ± 1.13 hours postoperatively in the intervention group and 4.7 ± 1.52 hours postoperatively in the control group (

Table 4. Postoperative Feeding Onset Time in Both Groups.

and Figure 3). The mean duration of feeding onset in the intervention group was less than that in the control group (P < .01).

Discussion

Local hemostatic agents play a crucial role in managing trauma, surgery, angiographic catheters, vascular problems, etc. Some of these factors cause protein coagulation and deposition, causing small cutaneous blood vessels to close, while others contribute to the later stages of the coagulation cascade and activate biological responses to bleeding. The ideal topical hemostatic drug should have a significant hemostatic effect, low tissue response, and easy sterilization, and should be biodegradable in the body, inexpensive, and useful for specific needs [10]. Chitohem absorbable bleeding control powder, which contains cellulose oxide particles, controls venous, capillary, and small arterial bleeding. Cellulose oxide is prepared from wood pulp containing more than 50% cellulose and then regenerated for purification. In addition to controlling bleeding and accelerating coagulation, this substance is also effective in the wound healing process. Its effects in preventing bacterial infection have been identified and proved effective against a wide range of aerobic and anaerobic bacteria. On the one hand, due to its high absorption power, Chitohem absorbs serum fluids and increases the concentration of important blood-clotting elements. On the other hand, its positive electric charge absorbs negatively charged molecules in the blood, thus accelerating the clotting process [10]. One of the most important features and benefits of Chitohem powder is that it quickly stops venous and arterial bleeding, reduces the patient’s hospital stay, solubility, and absorption, reduces the need for blood transfusions, is easy to use, and is non-allergenic. When Chitohem powder is sprayed on the wound, as soon as it comes in contact with blood or exudate and hand pressure on the wound, it quickly forms a physical barrier or strong adhesive that completely covers the wound and causes homeostasis [10]. In the present study, Chitohem powder significantly reduced early bleeding with analgesics usage in patients who underwent tonsillectomy by cold dissection compared to the control group. It should be noted that if the patient had active bleeding in the first 24 hours, would be transferred to the operating room again and treated with therapeutic methods (depending on the patient’s condition with suture and concomitant use of Chitohem powder along with this standard method alone); That is, the powder was poured into the bleeding tonsil bed and the anterior and posterior pillars were sutured. However, if the bleeding occurred 24 hours after surgery (usually 6 to 8 days after surgery), the patient should be referred to a hospital immediately on the advice of a physician. If active bleeding was seen on examination (with checking hemoglobin), the patient had been transferred to the operating room, then after 24 hours of monitoring, if there was no rebleeding, the patient was discharged. Although there were no bleeding signs in the patient’s examination and hemoglobin amount in 24 hours hospital monitoring, the patient was discharged.

According to the results of their research, Shafaeifard et al. [11] found that Chitohem powder in dental sockets reduces the bleeding duration and improves postop wound healing after tooth extraction. Hajizadeh et al. [12], by evaluating the efficacy of Chitohem powder in controlling bleeding after femoral angiography in comparison with sandbags packing, concluded that Chitohem powder has significant positive effects in controlling bleeding and reduces the homeostasis time of angiography. For this reason, the use of Chitohem powder after coronary angiography was approved and suggested by these researchers. Also, Kordestani et al. [13] studied the effect of using topical hemorrhage suppressant powder on patients undergoing angiography and reported that the powder reduces homeostasis and discharge time. The use of sandbags packing is the best choice. There has been a large body of research on other homeostasis factors, and most of the results indicate that these factors effectively control pain and bleeding caused by surgery. For instance, the results of research by Chamanzari et al. [14] showed that the use of cellulose powder (Celox powder) reduces the homeostasis time of vascular access in hemodialysis patients. Therefore, Celox usage was recommended in patients with vascular delayed access. Hejazi et al. [15] also suggested using Celox powder after coronary angiography due to its significant positive effects in controlling bleeding, reducing pain, and reducing the homeostasis time of angiography. Brown et al. [16] collected data from a civilian emergency medical service and concluded that Celox controlled bleeding in 79% of cases, whereas standard treatment failed. Wedmore et al. [17] also showed that Celox was successful in all cases of wounds where gauze packing has failed, and homeostasis was established wherever physicians could clearly see the dressing. The results of a study by Mortazavi et al. [18] showed the effect of the Cool Clot coagulation factor in reducing the time required to stop bleeding in the animal model of dogs and reducing the time of clot formation in human blood samples. Nouri et al. [19] stated that calcium sulphate and ferric sulphate could control hepatic hemorrhage and are effective hemostatic agents in controlling hepatic hemorrhage in the animal model. In another study [20], researchers introduced aluminium chloride as an effective hemostatic agent in controlling liver bleeding in an animal model. In a study by Hashemi Tair et al. [21], the use of fibrin adhesive in rabbit liver incisions significantly reduced bleeding time and blood loss compared to control incisions. The researchers concluded that fibrin adhesive, which is formed from fibrinogen and thrombin deposition, introduces a new therapeutic approach to fibrin adhesive preparation for clinical uses. In general, due to this Chitohem powder’s properties as a strong adsorbent, when applied to the site of rupture or bleeding, blood serum is absorbed and bleeding from the site is reduced, rapidly activating platelets and coagulation, which is more effective [22]. Platelet activation at the site of injury by cellulose oxide is mediated by factor XII [11], so in patients with factor XII deficiency, this activation is delayed [23]. Also, in the present study, a reduction in postoperative pain was observed in the patients who underwent the intervention compared with the control group. In the clinical trial of Mirzaei et al. [22], which was performed on patients with under-rectal surgery, hemostatic effects, and postoperative pain reduction were remarkable in Chitohem powder trying compared to electrocautery procedure. According to the results of their research, Shafaeifard et al. [11] stated that Chitohem powder in dental sockets reduces the amount of pain up to 3 days after surgery. Our results might be due to faster formation of fibrin layer in our intervention group who recovered faster starting with oral nutrition with a faster return to daily activities as well as better wound healings [23]. However, these effects may be due to the role of platelet growth factor (PDGF). The platelet growth factor is a potent activator of renal cell regeneration that stimulates chemotaxis, the expression of new genes in monocyte-macrophage cells, and fibroblasts, the repair cells in the body [24]. PDGF also enhances collagen production and muscle cell repair, mainly through macrophages, and plays an important role in wound healing initiation. (36). These effects can lead to pain relief, earlier onset of fibrin layer formation, earlier onset of oral nutrition, and faster recovery. Ewelina et al. [25] investigated the role of platelets in homeostasis and wound healing, reporting that more than 300 active substances released from platelet intracellular granules play an effective role in wound healing and biological activities, anti-inflammatory properties, and homeostasis. Also, the bactericidal effects of cellulose oxide can reduce the risk of infection, which is a rare complication after tonsillectomy surgery. This role, together with the effect of PDGF in the better repair of the surgical site, can effectively reduce patients’ pain and analgesics usage. In general, according to our data and the data from previous studies cited here, Chitohem powder seems to be eligible for patients undergoing total tonsillectomy and in patients with postoperative bleeding of total tonsillectomy.

Conclusion

The results of this study showed that the use of Chitohem powder in total tonsillectomy could reduce bleeding, analgesics usage, and the time of feeding onset.

To achieve more accurate and citational results, it is suggested that the present study be performed in several consecutive years and in several medical centers along with increasing the sample size. The results of this research could be a basis for future research.