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Tonsillectomy clinical trials

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NCT ID: NCT05270109 Recruiting - Tonsillectomy Clinical Trials

Cold Steel Versus "Hot" BiZact Tonsillectomy; Comparing Post Tonsillectomy Morbidity

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

Tonsillectomy, with or without adenoidectomy, in both children and adults is worldwide one of the most commonly performed surgical procedures in otorhinolaryngology, and the number is increasing. Alone in Denmark, approximately 8.000 tonsillectomies are performed annually. Although, tonsillectomy on benign indication is considered to be a minor and frequently performed surgical procedure, the operation is associated with significant morbidity. Postoperative pain and post tonsillectomy haemorrhage (PTH) are the most frequent, and PTH is potentially life threatening. In cold steel tonsillectomy, the peritonsillar space is dissected with metal instruments, and bleeding is typically controlled by ligation or electrocautery. This method has been used for the past 50 years, and is considered the "Gold Standard". However, new so-called "hot techniques have been developed. One of these is an impedance-dependent tissue sealer device (BiZactTM). The equipment used for BiZactTM tonsillectomy is EC certificated (CE nr. 00500). The equipment is commonly used for tonsillectomy both internationally and in Denmark, and preliminary results in both adults and children are promising. However, when a gold standard technique is replaced by a new technique, it is recommended that the decision is based on evidence obtained in randomized controlled designs, and preferably as a multicenter study. Within the scope of the CE marking of the equipment, the purpose of the present study is to conduct a randomized controlled trial (RCT) in order to investigate whether tonsillectomy performed with BiZactTM "hot" technique is beneficial or at least non-inferior compared to the gold standard cold steel technique in terms of affecting the incidence of post-tonsillectomy morbidity, interoperative factors, patient satisfaction, and health related quality of life.

NCT ID: NCT05206799 Recruiting - Child Clinical Trials

The CMCPCTH Research in Chinese Children

Start date: January 15, 2022
Phase:
Study type: Observational

To obtain hemorrhage rate after coblation tonsillectomy, and to investigate risk factors of hemorrhage after coblation tonsillectomy in children.

NCT ID: NCT05161754 Recruiting - Tonsillectomy Clinical Trials

Tonsillectomy and Risk of Post-Tonsillectomy Hemorrhage

Start date: March 28, 2022
Phase: N/A
Study type: Interventional

Post-tonsillectomy hemorrhage (PTH) is a feared complication to tonsillectomy. Tonsillectomy may be performed using different surgical techniques, which include both "cold" and "hot" dissection and hemostasis - but the technique may have a great impact on the risk of PTH. As of today there is no standard on how to perform hemostasis during tonsillectomy in Denmark. The aim of this study is to clarify whether cold dissection with either cold or hot hemostasis during the surgical procedure of tonsillectomy holds the lowest risk of PTH. Secondary objective is to address whether there is a difference in pain perception associated with the two procedures. The null hypothesis is that there is no difference in PTH between cold and hot hemostasis in tonsillectomy.

NCT ID: NCT05158348 Recruiting - Dexmedetomidine Clinical Trials

A Comparative Study to Measure the Effect of Nebulized Dexmedetomidine

Start date: November 5, 2021
Phase: Phase 3
Study type: Interventional

A comparative study to measure the effect of nebulized dexmedetomidine - lidocaine for controlling postoperative pain after tonsillectomy in adults.

NCT ID: NCT05099302 Completed - Fear Clinical Trials

The Effect of Cartoons Watched Before Surgery on Children's Fear Level

Start date: January 14, 2021
Phase: N/A
Study type: Interventional

This study was conducted as a randomized controlled experimental study to determine the effect of cartoon in reducing pre-operative fear in children aged 4-10 years who came to the operating room. The data of the study were obtained from children between 4-10 years old who came to Mersin University Hospital Operating Room Unit between 1 July and 30 August 2020. The sample size was determined as a total of 116 children, including 58 children for each group. "Observation Form, Children's Fear Scale (CFS), Tablet Computer, Stopwatch" was used for data collection. The data were evaluated using percentage, mean, standard deviation, chi-square, t test, Anova and Tukey advanced analysis test. Cartoons group; When the children came to the operating room waiting room, the first stopwatch was started as soon as they entered the room to determine the length of stay in the waiting room, and it was turned off while they were entering the operating room with the anesthesiologist. Thus, the total length of stay in the room was determined and recorded. The second stopwatch was started as soon as the child began to cry, and was turned off when the crying stopped. Thus, the crying time of each child was also evaluated. After each parent signed the Informed Consent Form, the Interview and Observation Form was filled. Then the child's heart rate was measured and recorded. The child's fear level was evaluated separately by the child, parent and observer via CFS and recorded in the data collection form. After the initial assessment was completed, the child was asked if he wanted to watch cartoons. "Snow Queen" for girls who want to watch cartoons and "Spider-Man" cartoons for boys started to be watched by tablet. The period of watching cartoons lasted until the child left the waiting room. The heart rate was measured just before the child left the waiting room at the time of surgery. The level of fear was evaluated separately by the child, parent and observer via CFS and recorded in the form. Then, the child was taken to the operating room with the anesthesiologist and observer. Parents are separated from their children in the waiting room. After the child who came to the operating room was taken to the operating table, the pulse rate and the level of fear were evaluated and recorded by the observer via CFS. Control group: All processing steps were carried out similarly to the cartoon group. In this group, the option of playing toys was offered instead of cartoons.

NCT ID: NCT04910919 Withdrawn - Tonsillectomy Clinical Trials

Here's the Buzz: Evaluating Pediatric Post Op Pain and Nausea Following Tonsillectomy Surgery

Start date: March 2022
Phase: N/A
Study type: Interventional

Tonsillectomy is one of the most common surgeries performed in the United States, with over half a million performed annually in children younger than 15 years of age. Postoperative pain is one of the most common clinical problems and may lead to poor intake, dehydration, and weight loss. Management of postoperative pain is often challenging and results in additional medical costs due to unplanned emergency room visits. Opioids such as codeine are commonly prescribed for pain control, however in 2013 the Food & Drug Administration issued a black box warning for the use of codeine in post-tonsillectomy pediatric patients. The American Academy of Otolaryngology-Head and Neck Surgery recommends the use of acetaminophen and ibuprofen to successfully manage postoperative pain. With an extended recovery period, often longer than 7 days, alternative measures to reduce postoperative pain are needed. Honey has been proven to possess antibacterial and anti-inflammatory properties. This intervention will evaluate the effect of Tylenol, ibuprofen with honey on children's postoperative pain and nausea following tonsillectomy surgery.

NCT ID: NCT04725305 Recruiting - Postoperative Pain Clinical Trials

BiZact Tonsillectomy in the Pediatric Population

Start date: June 6, 2021
Phase: N/A
Study type: Interventional

This study has been designed to evaluate how effective the Bizact tonsillectomy device is in reducing operating time and complications that occur after surgery. This device operates in a different way than the standard device that is used for most tonsillectomies. In 2019, a study was conducted in 186 children and adults using this device in tonsillectomies. Results showed lower blood loss and shortened time in surgery. However, the rate for bleeding as a complication after surgery was the same as other procedures that are used in tonsillectomy

NCT ID: NCT04640610 Withdrawn - Tonsillectomy Clinical Trials

Angiotensin-converting Enzyme 2 (ACE2) Expression in Tonsils and Adenoids

ACE2-AVG
Start date: June 30, 2021
Phase:
Study type: Observational

The objective of the research is to study the expression of the ACE 2 receptor and the TMPRSS2 serine protease in the tonsils and adenoids of children and adults.

NCT ID: NCT04320095 Not yet recruiting - Tonsillectomy Clinical Trials

Tonsillectomy Using BiZact Tonsilletomy Device

Start date: June 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to describe how Bizact Tonsillectomy Device might affect operative time and intraoperative blood loss in pediatric patients undergoing tonsillectomy, and compare these parameters to the standard technique in tonsillectomy at our institution, which is electrocautery.

NCT ID: NCT04273035 Recruiting - Tonsillectomy Clinical Trials

Handheld-multimedia Versus Oral Midazolam in Pediatric on Perioperative Anxiety

Start date: February 1, 2020
Phase: Phase 4
Study type: Interventional

The first goal of this study is to compare the efficacy and safety between anxiolysis by multimedia-distraction with an IPAD versus anxiolysis by premedication with midazolam prior to the induction. Secondly to evaluate the need for midazolam-premedication in pediatric day-care patients induced by inhalational anesthesia.