Each participant uses 6 weeks of Saline first (Frequency= 2 sprays twice daily; Route= topical intra-nasal spray; Duration= 6 weeks) followed by 6 weeks of silver colloid (Dose= 6.7mcg silver daily; Frequency= 2 sprays twice daily; Route= Topical intra-nasal spray; Duration= 6 weeks)

Each participant uses 6 weeks of Silver Colloid first (Dose= 6.7mcg silver daily; Frequency= 2 sprays twice daily; Route= Topical intra-nasal spray; Duration= 6 weeks) followed by 6 weeks of saline (Frequency= 2 sprays twice daily; Route= topical intra-nasal spray; Duration= 6 weeks).

Each participant uses 6 weeks of saline (Frequency= 2 sprays twice daily; Route= topical intra-nasal spray; Duration= 6 weeks) followed by 6 weeks of silver colloid (Dose= 6.7mcg silver daily; Frequency= 2 sprays twice daily; Route= Topical intra-nasal spray; Duration= 6 weeks)

Saline Then Silver Colloid

Each participant uses 6 weeks of silver colloid (Dose= 6.7mcg silver daily; Frequency= 2 sprays twice daily; Route= Topical intra-nasal spray; Duration= 6 weeks) followed by 6 weeks of saline (Frequency= 2 sprays twice daily; Route= topical intra-nasal spray; Duration= 6 weeks).

Silver Colloid Then Saline

Total

Sex: Female, Male

Race and Ethnicity Not Collected

Region of Enrollment

The SNOT-22 questionnaire is a 22-item document that assesses the social and emotional impact of CRS. Scores may range from 0-110 with higher scores representing more severe disease

SNOT-22 score

The Lund Kennedy endoscopic score is an objective measure of the severity of CRS. Scores are given to reflect the degree of edema and obstruction within the various sinuses. Scores range from 0 to 12 with higher scores being worse.

Lund-Kennedy endoscopic score

The Sinonasal Outcome Test-22 is a quality of life questionnaire examining the social and emotional distress of CRS. The scores range from 0 to 110 with higher scores representing more severe disease. Total score is reported. Higher values are a worse outcome.

Cross-over control Each participant does 6 weeks of topical nasal saline, followed by 6 weeks of topical nasal silver colloid (Dose= 6.7mcg silver daily; Frequency= 2 sprays in each nostril daily; Route= Topical intra-nasal spray; Duration= 3 months)
Topical silver colloid: Patients will be provided with a standardized silver colloid spray and asked to place two sprays into each nostril daily for a total of three consecutive months. The commercially available silver colloid product, Sovereign Silver Mineral Supplement, will be used.

Saline, Then Silver Colloid

Each participant receives the full 12 weeks of topical nasal silver colloid (Dose= 6.7mcg silver daily; Frequency= 2 sprays in each nostril daily; Route= Topical intra-nasal spray; Duration= 3 months)
Topical silver colloid: Patients will be provided with a standardized silver colloid spray and asked to place two sprays into each nostril daily for a total of three consecutive months. The commercially available silver colloid product, Sovereign Silver Mineral Supplement, will be used.

Silver Colloid, Then Saline

Change in Sino-nasal Outcome Test-22 Score Between Baseline and 6 Weeks, Then 6 Weeks to 12 Weeks.

Endoscopic evaluation of the individual paranasal sinuses (left and right) and the degree of obstruction of the osteomeatal unit. Scores range from 0 to 24 with a higher number representing more severe disease.

Each participant uses 6 weeks of Saline first (Frequency= 2 sprays twice daily; Route= topical intra-nasal spray; Duration= 6 weeks) followed by 6 weeks of silver colloid (Dose= 6.7mcg silver daily; Frequency= 2 sprays twice daily; Route= Topical intra-nasal spray; Duration= 6 weeks)
Silver Colloid: Topical silver colloid will be administered for 6 weeks. This will either occur before topical saline nasal spray. Participants are randomized as to the order of sprays. The commercially available silver colloid product, Sovereign Silver Mineral Supplement, will be used.
Saline: Topical saline will be administered for 6 weeks. This will occur before the topical silver colloidal nasal spray. Participants are randomized as to the order of sprays.

Each participant uses 6 weeks of Silver Colloid first (Dose= 6.7mcg silver daily; Frequency= 2 sprays twice daily; Route= Topical intra-nasal spray; Duration= 6 weeks) followed by 6 weeks of saline (Frequency= 2 sprays twice daily; Route= topical intra-nasal spray; Duration= 6 weeks).
Silver Colloid: Topical silver colloid will be administered for 6 weeks. This will either occur before topical saline nasal spray. Participants are randomized as to the order of sprays. The commercially available silver colloid product, Sovereign Silver Mineral Supplement, will be used.
Saline: Topical saline will be administered for 6 weeks. This will occur before the topical silver colloidal nasal spray. Participants are randomized as to the order of sprays.

Change in Endoscopic Lund-Kennedy Score From Baseline to 6 Weeks, Then 6 Weeks to 12 Weeks

Cross-over control Each participant does 6 weeks of topical nasal saline, followed by 6 weeks of topical nasal silver colloid (Dose= 6.7mcg silver daily; Frequency= 2 sprays in each nostril twice daily; Route= Topical intra-nasal spray; Duration= 6 weeks)
Topical silver colloid: Patients will be provided with a standardized silver colloid spray and asked to place two sprays into each nostril twice daily for a total of 6 weeks. The commercially available silver colloid product, Sovereign Silver Mineral Supplement, will be used.
Topical Saline

Cross-over control Each participant receives 6 weeks of topical nasal silver colloid, followed by 6 weeks of saline (Dose= 6.7mcg silver daily; Frequency= 2 sprays in each nostril twice daily; Route= Topical intra-nasal spray; Duration= 6 weeks)
Topical silver colloid: Patients will be provided with a standardized silver colloid spray and asked to place two sprays into each nostril twice daily for a total of 6 weeks. The commercially available silver colloid product, Sovereign Silver Mineral Supplement, will be used.

Overall Study

Dr. Leigh Sowerby

Adverse events that occurred during time using saline intervention are reported here.

Saline Intervention

Adverse events that occurred during time using colloidal silver intervention are reported here.

Colloidal Silver Intervention

Rhinosinusitis

Topical silver colloid will be administered for 6 weeks. This will either occur before topical saline nasal spray. Participants are randomized as to the order of sprays. The commercially available silver colloid product, Sovereign Silver Mineral Supplement, will be used.

Silver Colloid

Topical saline will be administered for 6 weeks. This will occur before the topical silver colloidal nasal spray. Participants are randomized as to the order of sprays.

Saline

Saint Joseph's Health Care

St. Joseph's Health Care

The Effectiveness of Topical Silver Colloid in Treating Patients With Recalcitrant Chronic Rhinosinusitis

Phase 2 Study Examining the Effects of Topical Intranasal Silver Colloid in Patients With Recalcitrant Chronic Rhinosinusitis

Leigh Sowerby

Assistant Professor

Lawson Health Research Institute

(A) Scheduled tramadol 1mg/kg Q6h [max. 50mg] for 5 days; plus tramadol 1mg/kg Q6h PRN [max. 50mg] for 5 days (B) Scheduled gabapentin 3 mg/kg [max 150 mg] Q6h for 5 days (C) PRN ibuprofen 10 mg/kg [max. 500 mg] Q6h PRN

(A) Scheduled tramadol 1mg/kg Q6h [max. 50mg] for 5 days; plus tramadol 1mg/kg Q6h PRN [max. 50mg] for 5 days (B) Scheduled placebo of same volume Q6h for 5 days (C) PRN ibuprofen 10 mg/kg [max. 500 mg] Q6h PRN

Pain

The active comparator arm will receive gabapentin as per dosing specifics listed in the study arm description.

gabapentin

Both study arms will receive tramadol per dosing details listed in the study arm descriptions.

Tramadol

Both study arms will receive as needed (PRN) ibuprofen to take home.

Ibuprofen

Placebo

Children's Hospitals and Clinics of Minnesota

Postoperative Tramadol/Gabapentin/Ibuprofen Versus Tramadol/Placebo/Ibuprofen

A Comparison of Postoperative Tramadol/Gabapentin/Ibuprofen Versus Tramadol/Placebo/Ibuprofen in Children Undergoing Tonsillectomy

To compare the efficacy of scheduled tramadol + PRN ibuprofen/tramadol vs. scheduled tramadol + scheduled gabapentin + PRN ibuprofen/tramadol for pain management during the post-tonsillectomy recovery period. Efficacy will be measured through daily collection of three pain scores (FACES or numeric; 0-10 rating): "pain right now," "typical pain over the past 24 hours," and "worst pain in the past 24 hours." Efficacy will also be measured daily with: 1) the Parents' Postoperative Pain Measure, 2) the number of times "as needed" medication is given by parents, 3) sleep quality, and 4) global satisfaction with pain management and recovery (on day 10 only). All efficacy measures will be recorded in a take-home diary by parents for 10 days postoperatively.

To evaluate the side effects of scheduled tramadol + PRN ibuprofen/tramadol vs. scheduled tramadol + scheduled gabapentin + PRN ibuprofen/tramadol during the post-tonsillectomy recovery period. Safety will be measured through use of a daily take-home diary that the parents fill out, and through phone calls made to parents by the study coordinator every two days during the 10-day recovery period. Specifically, parents will document, on a daily basis, number and occurence of any side effects (e.g., vomiting, dizziness), number of doctor and emergency room visits, length of stay in days (if applicable), and the purpose and location of any medical visits.

facial pain/seizures

The Effectiveness of Topical Silver Colloid in Treating Patients With Recalcitrant Chronic Rhinosinusitis

Postoperative Tramadol/Gabapentin/Ibuprofen Versus Tramadol/Placebo/Ibuprofen

Studies of Dextromethorphan and Topiramate to Treat Oral and Facial Pain

Den mest kompletta databasen med medicinska örter som stöds av vetenskapen