Intrasound Gel by TriStar Online Sales Corp

POSSIBLY EFFECTIVE

• Oral mucositis. Using 15 mL of a mouthwash containing a 1:1 mixture of kaolin-pectin and diphenhydramine syrup held in the mouth for 3 minutes after meals and at bedtime for 3 weeks helps to reduce pain associated with radiation-induced mucositis (186). A similar mouthwash containing a 1:1:1 mixture of kaolin pectin, diphenhydramine, and saline also helps to reduce pain associated with radiation- or chemotherapy-induced mucositis when used for the duration of therapy in amounts and frequency chosen by the patient. The mouthwash is either gargled and expectorated or applied to mouth lesions with a sponge (187).
• Bleeding. Kaolin-impregnated gauze has shown some benefit for reducing bleeding in various situations, including post-procedural bleeding, postoperative bleeding, and bleeding associated with wound debridement. In patients undergoing PCI or coronary angiography, research on the use of kaolin is conflicting. One clinical study in patients post-PCI shows that femoral artery compression using a kaolin-impregnated gauze (QuikClot Interventional Hemostatic Bandage, Z-Medica) stops bleeding about 20 minutes faster than manual compression alone. Rates of oozing, major or minor bleeding, and vascular complications were similar between the two groups (95080). A similar clinical study shows reduced bleeding times with the same kaolin-impregnated gauze when compared with conventional sterile gauze. In this study, the PCI access route was trans-radial, which can be associated with an increased risk of radial artery occlusion. The kaolin-impregnated gauze was not associated with an increase in the incidence of this complication (101215). Conversely, a clinical study in patients undergoing first-time elective diagnostic coronary angiography with or without PCI via forearm access shows that use of compression with kaolin-impregnated gauze (QuikClot Radial, Z-Medica) is associated with successful hemostasis in 92% of patients, compared with 100% of patients treated with standard mechanical compression control. Procedures performed via trans-radial access were associated with successful hemostasis rates of 90% and 100% in the kaolin and control groups, respectively. Patients receiving kaolin treatment reported less pain regardless of forearm access site, and rates of access complications were similar between groups (105860). Some research has shown benefit with the use of a specific kaolin-impregnated gauze (QuickClot Combat Gauze, Z-Medica) for postoperative bleeding. Preliminary clinical research in patients undergoing tonsillectomy shows that postoperative application of this gauze to the wound site stops bleeding faster than applying surgical cotton gauze. About 85% of patients treated with the kaolin-impregnated gauze stopped bleeding within 5 minutes of gauze application, compared with only 35% of patients treated with cotton gauze. The kaolin-impregnated gauze also reduced operating time by 8.5 minutes, intraoperative blood loss by about 20 mL, and number of stiches used by about 2 when compared to surgical cotton gauze (95079). In patients with severe pelvic fractures and associated hemodynamic instability, a retrospective study shows that preperitoneal pelvic packing with this specific kaolin-impregnated gauze and surgical pads is associated with a reduction in 12-hour mean transfusion volume requirement when compared with a control group packed with surgical pads alone. No effect on hemorrhage-induced mortality was observed (105861). Kaolin has also been evaluated for bleeding associated with wound debridement. A small clinical study in outpatients with Wagner grade I or II diabetic foot ulcers who are receiving antiplatelet and/or anticoagulant therapy shows that use of a kaolin-impregnated gauze stops bleeding faster than applying standard sterile dry gauze. Ten of 12 patients treated with kaolin-impregnated gauze stopped bleeding within 5 minutes of application, compared with only 5 of 12 patients treated with standard sterile drug gauze. After 5 more minutes had elapsed, all patients treated with kaolin-impregnated gauze had achieved complete hemostasis, compared with 7 of 12 patients treated with standard sterile drug gauze (105859). There is insufficient reliable information available about the effectiveness of kaolin for its other uses.

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LIKELY SAFE ...when used orally in food amounts. Kaolin has Generally Recognized as Safe (GRAS) status in the US (4912). ...when used topically as a component of specific wound dressings (QuikClot, Z-Medica) (95079,95080,101215). These wound dressings are an FDA-approved device (95080).

POSSIBLY SAFE ...when used orally as kaolin-pectin in medicinal amounts. ...when used topically as a mouthwash in appropriate amounts four times daily for 3 weeks (186).

POSSIBLY UNSAFE ...when used orally in large amounts. Intestinal obstruction, which can be fatal, and iron deficiency anemia have been reported (101216,101218,105862).

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in food amounts. Kaolin has Generally Recognized as Safe (GRAS) status in the US (4912).

PREGNANCY AND LACTATION: POSSIBLY SAFE
when used orally as kaolin-pectin in appropriate amounts (12576).

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General ...Orally, kaolin can cause constipation, particularly in children and the elderly (15). It can also cause intestinal obstruction (101216). After inhalation, kaolin may cause occupational kalinosis (pulmonary disease) (195,196,197).

Gastrointestinal ...Orally, kaolin can cause constipation, particularly in children and the elderly (15). When consumed in large quantities, kaolin can cause intestinal obstruction, which can be fatal in severe cases (101216). It can also interfere with absorption of nutrients. Several case reports describe patients presenting with pelvic and abdominal pain, headache, lightheadedness with presyncope, intermittent constipation, and severe iron deficiency anemia after taking kaolin daily for 2-3 years (101218,105862).

Pulmonary/Respiratory ...Occupational kalinosis (pulmonary disease) is reported in miners following inhalation of kaolin (195,196,197).

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