Clinical Research Directory

Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study

Emergence delirium (ED) is a frequent complication in children undergoing general anesthesia, particularly following ENT procedures such as adenotonsillectomy. Alpha-2 adrenergic agonists, such as clonidine and dexmedetomidine, are commonly used in pediatric anesthesia for their sedative, analgesic, and ED-reducing properties.The purpose of this prospective observational study (CLONIDEX) is to evaluate and compare the occurrence of emergence delirium, Post-Anesthesia Care Unit (PACU) length of stay, and overall time to hospital discharge in pediatric patients undergoing (adeno)tonsillectomy with or without placement of myringotomy tubes who receive intravenous dexmedetomidine, intravenous clonidine, or no alpha-2 agonist as part of their standard anesthetic care.

EXPAREL Post-tonsillectomy Clinical Trial

Tonsillectomy is one of the most commonly performed surgical procedures in the United States. The primary indications for tonsillectomy in the adult population include recurrent pharyngitis, chronic tonsillitis, and obstructive pathology. Tonsillectomy is often associated with severe postoperative pain, which can result in prolonged poor oral intake, dehydration, and the need for high dose narcotics. In severely dehydrated patients, epithelial shedding and necrosis of soft tissues at the surgical site can lead to postoperative complications such as bleeding, delayed healing, and severe pain. The goal for this study is to explore the use of a long acting local anesthetic bupivacaine liposome injectable suspension (Exparel) to manage pain experienced by adult patients after tonsillectomy

Coblator Wand Comparative Analysis

This study will address the gap in coblator wands by comparing the performance of reprocessed coblator wands with new wands in terms of efficiency and technical issues. As part of the evaluation, the investigator team will conduct the technical performance of the life cycle assessment of reprocessed versus new coblation wands based on the methodology described in the literature (see References) in studies of laryngoscopes.

Analgesic Efficacy of Peritonsillar Ropivacaine Infiltration After Tonsillectomy in Children

Tonsillectomy is one of the most frequently performed surgical procedures in children and is commonly associated with significant postoperative pain. Peritonsillar infiltration with local anesthetics such as Ropivacaine has been proposed to improve analgesia, but evidence remains inconsistent. This study aimed to evaluate the analgesic efficacy of peritonsillar Ropivacaine infiltration in pediatric tonsillectomy.

Suzetrigine in Tonsillectomy for Opioid-sparing Pain Management

The goal of this clinical trial is to learn if a non-opioid pain medicine called suzetrigine can lower how much opioid pain medicine adults need after tonsil surgery (tonsillectomy) or a similar throat surgery.

Impact of EEG-guided Sevofluorane on Opioid Consumption and Quality of Awakening

This prospective, randomized, single-blind, two-arm parallel-group clinical trial evaluates whether EEG-guided sevoflurane titration affects intraoperative opioid consumption and emergence quality in children undergoing painful elective surgery without regional anesthesia. Children aged 2-8 years (ASA I-II) scheduled for elective tonsillectomy (±adenoidectomy) are randomized 1:1 to a Control Group (standard 1 age-adjusted MAC; EEG screen concealed) or a Study Group (sevoflurane titrated to a stable slow-delta/alpha EEG pattern, SEF 17-20 Hz, starting at \~0.7 MAC). In both arms, fentanyl (0.5-1 mcg/kg IV) is added when nociception signs occur. The primary outcome is intraoperative fentanyl consumption (mean mcg/kg rate). Secondary outcomes include sevoflurane exposure (EtSevo, MAC-hours), EEG burst suppression, emergence time, emergence delirium (PAED scale), postoperative pain and opioid use, and hemodynamic events. Sample size: 50 participants (25/arm; 90% power, α=0.05, expected difference 2 mcg/kg, SD=2). EEG spectral analysis is performed in MATLAB using multitaper frequency-domain bootstrap. The study has institutional ethics approval; parental consent and patient assent (≥7 years) are obtained prior to enrollment.

Sphenopalatine Ganglion Block for Pain Relief After Pediatric Adenotonsillectomy

The aim of this clinical trial is to discover whether sphenopalatine ganglion block (SPGB) reduces postoperative pain in children aged 2 to 13 years undergoing tonsil surgery (with or without adenoid removal). The main questions it aims to answer are: * Does SPGB reduce postoperative pain in children undergoing throat surgery? * Do children who receive SPGB require less pain medication after surgery? * Do children who receive SPGB experience less nausea and vomiting after surgery? * Do children who receive SPGB experience less bleeding during and after surgery? * Do children who received SPGB experience fewer complications after surgery? Researchers will perform SPGB after the child has been placed under general anesthesia, before the surgeon begins the tonsil surgery. Each child will be randomly assigned to receive the SPGB with either a local anesthetic (ropivacaine) or a placebo (saline solution, which looks the same but contains no active medication). This allows researchers to compare pain outcomes between the two groups. To perform the SPGB, a long cotton-tipped applicator soaked in either the anesthetic or the saline solution is gently placed in each of the child's nostrils and left in place for 5-10 minutes before being removed.

Postoperative Care After Tonsillectomy

Tonsillectomy is one of the most common surgical procedures performed on both pediatric and adult patients; it is frequently associated with significant postoperative pain, difficulty swallowing, and the risk of complications such as bleeding and infection. The recovery period requires care aimed at minimizing discomfort, promoting healing, and preventing adverse events. Metabolic demands increase postoperatively due to surgical stress and the tissue repair process. Adequate nutrition, with a focus on protein intake, is fundamental for the synthesis of new proteins, the repair of injured tissues, and the maintenance of immune function-all essential for rapid, effective recovery and the prevention of complications. Insufficient protein intake can compromise surgical wound healing and the immune response. Additionally, the integrity and hydration of the oropharyngeal mucosa are crucial following a tonsillectomy. Surgical trauma and exposure to ambient air (especially after anesthesia and intubation) can lead to mucosal dryness, pain, discomfort, and scab formation, potentially hindering healing and increasing the risk of secondary infections. Micronebulization with saline solutions emerges as a potential intervention to hydrate the mucosa, alleviate discomfort, and promote the healing process. Despite the recognized importance of nutrition and local humidification, evidence regarding the combined impact of protein supplementation strategies and the use of micronebulizers on the recovery of patients undergoing tonsillectomy-specifically within a randomized clinical trial-requires further investigation. This study aims to contribute to the evidence base by evaluating the efficacy of these combined interventions on relevant clinical outcomes.

Effect of Preoprative Nebulized Dexmedetomidine Compared to Nebulized Lidocaine in Attenuating Sore Throat Following Tonsillectomy In Childern.

The aim of the study is to compare the effect of nebulized Dexmedetomidine compared to nebulized Lidocaine on postoperative sore throat in childern undergoing Tonsillectomy.

Screen-delivered Augmented-reality Preparation and Anxiety Before Pediatric Adenotonsillectomy in China

Whether a nonwearable, screen-delivered augmented-reality animation adds measurable benefit to supportive pediatric perioperative care remains uncertain. Preoperative anxiety has been reported in up to 60% of children and can compromise cooperation during anesthesia induction . Higher anxiety has also been associated with adverse postoperative behavior and, after adenoid or tonsillar surgery, with emergence agitation and pain . These consequences make anxiety reduction clinically relevant, particularly during the rapid transition from the waiting area to induction. Nonpharmacological preparation is central to child-centered perioperative care. Recent reviews encompass education, therapeutic play, caregiver presence, distraction, and digital interventions, but they also show substantial clinical and methodological heterogeneity. Meta-analyses suggest that virtual-reality interventions can reduce anxiety and may improve cooperation, although pooled effects vary across devices, comparators, and study quality . The evidence therefore supports promise rather than a single optimal format. Recent trials illustrate both the potential and the contextual dependence of digital preparation. Procedure-specific trials in adenotonsillectomy have reported benefits from visual explanation and virtual-reality cartoons. Virtual-reality education has been associated with lower anxiety and better induction cooperation . An immersive operating-room digital twin also outperformed an otherwise similar two-dimensional video in one randomized trial. Video distraction combined with caregiver presence reduced anxiety during transport and mask introduction , whereas tablet distraction produced anxiety outcomes similar to midazolam in preschool children . Delivery mode alone, however, does not explain the observed effects. Another trial found similarly low anxiety with three-dimensional virtual reality and two-dimensional video when caregivers remained present . A short animation added to verbal preparation showed no statistically significant between-group difference, and immediate virtual-reality exposure was more useful than exposure several days earlier . After correction of the published abstract, head-mounted augmented reality was associated with lower anxiety at induction, but fitting, tolerance, and workflow differ from shared-screen delivery . Evidence remains limited for a longer, nonwearable animation delivered within supportive usual care to children undergoing adenotonsillectomy. The investigators in this study therefore conducted a prospective nonrandomized controlled study of children undergoing adenotonsillectomy at a tertiary hospital in China. The investigators evaluated whether adding a 30-40-min screen-delivered augmented-reality animation to supportive usual care was associated with anxiety trajectories and induction cooperation. By assessing children at three perioperative transitions, the study distinguishes attenuation of rising distress from complete prevention. The study report these behavioral outcomes and then interpret their clinical relevance within the constraints of date-based allocation.

Topical Magnesium Sulfate Versus Peritonsillar Bupivacaine for Post-Tonsillectomy Pain Relief in Children

Tonsillectomy (tonsil removal) is a very common surgery for children, but it often causes significant throat and ear pain afterward. Doctors usually inject a numbing medicine, such as bupivacaine, into the area around the tonsils to help control this pain. However, these injections require needles, which can cause swelling, distort tissue, and slightly increase the risk of bleeding or infection, and the pain relief typically only lasts for about 4 to 6 hours. This study is investigating a needle-free alternative to see if it provides effective pain relief. The researchers are testing a medication called magnesium sulfate, which blocks certain pain receptors and can be applied directly to the surgical site using a soaked gauze pad instead of a needle injection. The main goal of this clinical trial is to compare how well topical magnesium sulfate relieves pain compared to standard bupivacaine injections in children undergoing tonsillectomy. The study will include 40 children between the ages of 8 and 15 years old. During the surgery, while under general anesthesia, half of the children will receive the topical magnesium sulfate pad applied to the surgical area for 5 minutes, and the other half will receive the standard bupivacaine injection. After the surgery, researchers will measure the children's pain levels using visual pain scales featuring faces and numbers. They will also track how much extra pain medication the children need, how well their surgical wounds heal, and if they experience any adverse effects.

SUPRATHEL 250 as a Treatment for Oropharyngeal Wounds

To assess the use of Suprathel 250 for mucosal reconstruction in oropharyngeal defects. The membrane will be applied after tonsillectomy procedures and compared to bare wounds' healing

Remimazolam for Emergence Delirium Prevention in Children Undergoing Tonsillectomy

The aim of this study is to confirm the effectiveness of remimazolam in preventing delirium during emergence from anesthesia in children who will undergo elective procedures of tonsillectomy, adenotonsillectomy or adenoidectomy, aged 3-12 years, American Society of Anesthesiologists (ASA) physical status I. Children will be anesthetized with balanced anesthesia, maintained with sevoflurane and will be randomized in two groups. The first group will receive remimazolam before anesthesia, while the second will receive normal saline, both intravenously. The main outcome of the study will be the presence/absence of delirium during anesthesia recovery, while the secondary outcome will be postoperative pain level, length of stay in the recovery room, presence of unwanted events in the recovery room, presence of postoperative mood changes, as well as parental satisfaction.

Comparing Two Agents Used to Stop Bleeding During Tonsil Removal Surgery: Adrenaline Versus Hydrogen Peroxide

The goal of this quasi-experimental study is to compare the effectiveness of topical adrenaline and 3% hydrogen peroxide for controlling bleeding (hemostasis) during tonsil removal surgery in patients aged 5 to 18 years. The main questions it aims to answer are: 1. Which substance leads to faster bleeding control during surgery? 2. Which substance results in less total blood loss during surgery? Researchers compared the adrenaline group to the hydrogen peroxide group to see if one agent was more effective at managing bleeding than the other. Participants underwent a tonsillectomy where surgeons applied either gauze soaked in adrenaline (1:100,000 solution) or gauze soaked in 3% hydrogen peroxide to the tonsil area to stop bleeding.

Weight-Adjusted Diclofenac Potassium Medicated Lollipop for Post-Adenotonsillectomy Pain in Children

\*\*Brief Summary\*\* This study aimed to develop and conduct a preliminary clinical evaluation of a novel weight-adjusted gelatin-based diclofenac potassium medicated lollipop for the management of postoperative pain following adenotonsillectomy in children. The formulation was designed to improve analgesic adherence by providing a palatable and child-friendly dosage form suitable for oral transmucosal administration. Fifty paediatric patients aged 4 to 12 years undergoing elective adenotonsillectomy received one of three weight-adjusted diclofenac potassium lollipop doses (15 mg, 20 mg, or 30 mg) every 8 hours during the first 24 postoperative hours. The study assessed postoperative pain intensity, product acceptability, rescue analgesic use, and safety. In parallel, the formulation underwent pharmaceutical characterization, including physicochemical and microbiological quality evaluation.

Evaluating the Efficacy of Intravenous Acetaminophen (IV Tylenol) in Reducing Pain and Agitation in Pediatric Patients Undergoing Elective Tonsillectomy and/or Adenoidectomy

MetroHealth's main campus administers IV Tylenol as part of its pain management protocol for elective tonsillectomy/adenoidectomy, whereas Parma campus does not. Comparing these practices provides an opportunity to evaluate the benefits of IV Tylenol for pain, agitation, and associated secondary outcomes in this population. The pain/agitation would be assessed with a validated tool PAED and FLACC

Ketamine Gargle for Pain After Pediatric Tonsillectomy

Post-tonsillectomy pain in children is a common and clinically significant problem that may lead to poor oral intake, dehydration, and delayed recovery. This study evaluates whether a simple preoperative intervention-gargling with ketamine-can reduce postoperative pain and improve recovery after pediatric adenotonsillectomy. In this randomized, double-blind, placebo-controlled trial, 420 children aged 4 to 12 years undergoing elective adenotonsillectomy were assigned to receive either a ketamine gargle (40 mg in saline) or a saline placebo prior to anesthesia induction. Pain intensity was measured using the Visual Analog Scale at multiple time points within the first 24 hours after surgery. Secondary outcomes included postoperative bleeding requiring reintervention, analgesic consumption, and adverse events. The study aims to determine whether topical ketamine provides effective and safe analgesia as part of an opioid-sparing strategy in pediatric airway surgery.

Effects of Adenoidectomy on Symptoms and IgE Levels in Children With AR

This study aims to evaluate the effects of conservative management versus surgical intervention (adenoidectomy alone or adenotonsillectomy) on symptoms and local IgE levels in children with allergic rhinitis (AR) accompanied with adenotonsillar hypertrophy. The primary objectives include the impact of conservative management and surgical interventions on AR symptoms and local IgE levels. The second outcomes include serum IgE levels, inflammatory cell profiles within the nasal mucosa, and postoperative complications.

Adenoidectomy: Correlation Between Individual Factors, Surgical Technique, and Residual Adenoids

Adenoidectomy is the most commonly performed otolaryngological surgical procedure in children. The removal of adenoid lymphoid tissue is intended to clear the nasopharynx and restore the patency of the nasal airways. In most cases, adenoidectomy leads to an improvement in symptoms and quality of life. However, in some patients, symptoms recur with the presence of lymphoid tissue obstructing the nasopharynx. In these cases, a surgical revision is often necessary. The traditional surgical technique is performed using an adenoid curette or Shambaugh adenotome without direct visualization of the surgical field. Among the known limitations of this surgery is the possibility of leaving intraoperative adenoid residues. In the literature, regarding the detection of adenoid vegetations in patients who have already undergone adenoidectomy, the term "regrowth" of lymphoid tissue is often used; however, this term is correctly applied only when there is certainty of complete adenoid excision during the procedure. In the absence of this certainty, it would therefore be more accurate to speak of persistence or recurrence of adenoid hypertrophy after adenoidectomy. However, this phenomenon is poorly understood due to the scarcity of information in the literature regarding the incidence, associated factors, and etiology of this clinical entity. In particular, there is still debate over whether the recurrence of symptoms following the detection of nasopharyngeal lymphoid tissue is due to incomplete surgical resection, or whether individual factors may coexist and contribute to the recurrence of adenoid lymphoid tissue. To date, the scientific literature has focused almost exclusively on intraoperative variables independent of the patient. The aim of this study is to evaluate whether there are patient-specific factors at the time of surgery-such as sex, age, weight, height, and soft palate length-that may influence the surgical efficacy of the traditional technique in terms of complete removal of adenoid lymphoid tissue.

Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Tonsillectomy

This study aims to compare the effect of ondansetron lozenge and intravenous for prevention of shivering in tonsillectomy.

Head-Only Draping in Pediatric Tonsillectomy

This single-center, interventional study will compare 30-day postoperative infection rates in pediatric tonsillectomy performed with either head-only draping or traditional full-body draping. Secondary analyses will evaluate differences in waste production, material and disposal costs, and provider attitudes between the two draping techniques. This study will randomize participants 1:1 to either the head-only draping cohort (intervention) or the full-body draping cohort (control).

Melatonin vs Midazolam in Children Undergoing Tonsillectomy

Used as a premedication to decrease anxiety (Caumo et al., 2007). Midazolam, though has several drawbacks (McCann and Kain, 2001). Hence, an alternative premedication to midazolam will definitely have a widespread appeal. Melatonin is a hormone secreted by the pineal gland. Melatonin is different from benzodiazepines and their derivatives in that it exerts a promoting effect on sleep by amplifying day/night differences in alertness and sleep quality and displaying a modest sleep-inducing effect, quite mild as compared to that seen with benzodiazepines (Ahmad et al., 2007). Melatonin has also been reported to cause preoperative anxiolysis and an increase in levels of sedation without impairing orientation (Naguib and Samarkandi, 2000). Hence, the aim of this study is to compare the effect of oral melatonin and oral midazolam on preoperative anxiety. Emergence delirium (ED) was first described in the literature in the early 1960s. Although often used interchangeably with emergence agitation, it is defined as a temporary dissociated state of consciousness after discontinuation of anesthesia. The characteristics that make up ED include irritability, inconsolable crying, distress and inability to cooperate (Reduque and Verghese, 2013). Midazolam is the most prescribed oral premedication in the preoperative setting. Its benefits include preoperative anxiolysis, amnesia, relatively rapid onset and short duration of action. Although most children have anxiolysis with midazolam, up to 29% may display a paradoxical agitation response (Shin et al., 2013). Oral melatonin doses up to 0.4 mg/kg (maximum 20 mg) are effective in reducing ED in children (age 3-7 years) (Kain et al., 2009). AIM OF THE WORK The study aims to compare the effects of oral melatonin and oral midazolam on preoperative anxiety as a premedication in children undergoing tonsillectomy.

Outpatient Management of Tonsillectomy in Adults

Tonsillectomy is a frequent surgical procedure in the ENT specialty but it can be a source of postoperative pain that can be important. These pains complicate the intake of food and in particular the intake of analgesic drugs per os and require the prolongation of the hospitalization in order to continue an intravenous analgesia. The aim is to set up a protocol for ambulatory care of adult tonsillectomies. Then, it would allow an improvement of the postoperative quality of life for the patient, who prefers a quicker return home.The study aims to allow patients to come back home early after tonsillectomies with intravenous analgesia. Pain, feeding and quality of life will be evaluated regularly through an application called MAELA during a few days after surgery. They will also be evaluated by nurses coming via providers.

Lateral Positioning for Extubation After Adenotonsillectomy

The postoperative recovery period following general anesthesia has been associated with a 30%-50% incidence of postoperative respiratory adverse events (PRAEs) in pediatric populations, including laryngospasm, airway obstruction, and hypoxemia. Despite the limited effects of existing pharmacological and operative interventions, positional optimization (e.g., lateral or semirecumbent position) may play a potential role by decreasing airway resistance and improving oxygenation. However, evidence-based evidence for its use in pediatric populations is still lacking, necessitating the urgent need for randomized controlled trials.