Prospective, Randomized, Controlled Trial of a Hemostatic Sealant in Children Undergoing Adenotonsillectomy

2007 ◽  
Vol 137 (3) ◽  
pp. 454-458 ◽  
Author(s):  
Stephen H. Jo ◽  
Ronald A. Mathiasen ◽  
Deepak Gurushanthaiah
Keyword(s):  
Randomized Controlled Trial ◽  
Blood Loss ◽  
Postoperative Morbidity ◽  
Controlled Trial ◽  
Safety And Efficacy ◽  
Randomized Controlled ◽  
Pain Medications ◽  
Prospective Randomized Controlled Trial ◽  
Cold Knife ◽  
To Receive

OBJECTIVES: To evaluate the efficacy of Floseal as a hemostatic sealant compared to traditional electrocautery hemostasis after cold knife adenotonsillectomy. STUDY DESIGN: Prospective, randomized, controlled trial of 68 consecutive patients undergoing cold steel adenotonsillectomy. Patients were randomized to receive either Floseal (FS) or electrocautery (EC) for hemostasis. RESULTS: FS patients had shorter operative times than EC patients (16 min vs 31.2 min, P < 0.0001) and less blood loss (49.2 mL vs 70.8 mL, P < 0.05). Four EC patients were crossed over to Floseal when adequate hemostasis could not be achieved in the adenoid bed. No Floseal patients were crossed over. FS patients had significantly less pain on postoperative days two through 11 ( P < 0.05) and less use of narcotic pain medications over the first 10 postoperative days ( P < 0.05). FS patients also had a faster return to regular diet (5.5 days vs 7.9 days, P < 0.01) and activity (5.3 days vs 7.8 days, P < 0.01) as compared to the EC patients. There were no significant complications in either group. CONCLUSIONS: Floseal is safe and efficacious, and decreases postoperative morbidity as compared to electrocautery hemostasis after cold steel adenotonsillectomy. SIGNIFICANCE: This study demonstrates the safety and efficacy of Floseal as a hemostatic method in children undergoing adenotonsillectomy.

scholarly journals A preinstalled nasopharyngeal airway in the right nasal passageway to facilitate nasogastric intubation in anesthetized and intubated patients: a prospective randomized controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Ting-Yang Huang ◽  
Jr-Rung Lin ◽  
Yung-Tai Chung
Keyword(s):  
Randomized Controlled Trial ◽  
Success Rate ◽  
Risk Reduction ◽  
Controlled Trial ◽  
Success Rates ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
Nasopharyngeal Airway ◽  
The Right ◽  
To Receive

Abstract Background Nasogastric intubation (NGI) is usually challenging in patients under general anesthesia, with reported success rate at the first attempt to be less than 50%. The aim of this study was to investigate whether a preinstalled nasopharyngeal airway (NPA) in the right nasal passageway can facilitate NGI in anesthetized and intubated patients. Methods A prospective randomized controlled trial including 108 patients scheduled for elective intra-abdominal surgeries requiring a nasogastric tube (NGT) was conducted. Fifty-three patients were randomized to receive NGI through a preinstalled NPA in the right nasal passageway (Group NPA) and 55 patients to receive NGI via the right nostril (Group O). The primary outcomes were success rates of NGI at first attempt, success rates of NGI in accumulative attempts, durations of successful NGI at the first attempt and success rates of NGI for the rescuing methods. The secondary outcomes were bleeding incidence and hemodynamic changes induced by NGI. Results Success rate of NGI at the first attempt was 83.0% in Group NPA compared with 47.3% in Group O [P < 0.001; absolute risk reduction (ARR) = 35.7%, 95% confidence interval (CI) = 19.1–52.4%; relative risk reduction (RRR) = 67.8%] and success rate of NGI in accumulative attempts (two attempts maximum) was 88.7% in Group NPA compared with 63.6% in Group O (P = 0.002; ARR = 25.0%, 95% CI = 9.7–40.4%; RRR = 68.9%). Duration for NGI successful at the first attempt in Group NPA was significantly longer than that in Group O (56.3 vs. 27.1 s; P < 0.001; Mean difference = 29.2 s, 95% CI = 20.0–38.4 s). Neither bleeding incidence nor hemodynamic response is significantly different between the two study groups. Conclusions The study indicates a preinstalled NPA in the right nasal passageway facilitates NGI in anesthetized and intubated patients as an initial NGI method and as a rescuing method for patients undergoing two unsuccessful initial attempts of NGI without a preinstalled NPA. However, the NPA method proved to take more time than the routine method for NGI successful at the first attempt. Trial registration: The study was conducted after receiving approval from Institutional Review Board of Chang Gung Memorial Hospital, Linkou branch, Taiwan (registration number 201800138A3; April 11, 2018), and the clinicaltrials.gov (NCT03697642; Principal Investigator: Ting-Yang Huang; Date of registration: October 4, 2018; https://www.clinicaltrials.gov/NCT03697642).

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