Opioid-Sparing Anesthesia for Pediatric Tonsil Surgery
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Boston Children's Hospital
Disqualifiers: Coagulopathies, Chronic pain, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?This is a prospective, randomized, controlled, non-inferiority study of patients undergoing tonsil surgeries at Boston Children's Hospital Waltham. The overall aim is to evaluate the efficacy of an opioid anesthetic plan (morphine, ketorolac, and acetaminophen versus an opioid sparing anesthetic plan (dexmedetomidine, ketorolac and acetaminophen) for perioperative analgesia and recovery time in patients undergoing tonsillectomies and tonsillotomies at Boston Children's Hospital Waltham. Secondary measures include rescue opioids administered in post-anesthesia care unit (PACU), re-operation secondary to bleeding, emergence delirium, post-operative nausea and vomiting, intraoperative hemodynamics, intraoperative vasopressor administration, and length of procedure.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Dexmedetomidine for pediatric tonsil surgery?
Research shows that Dexmedetomidine can reduce the need for opioids after tonsil surgery in children, as it provides pain relief and sedation without affecting breathing or causing bleeding issues.
12345Is dexmedetomidine safe for use in children undergoing surgery?
Dexmedetomidine is generally considered safe for use in children undergoing surgery, but it can cause side effects like low blood pressure (hypotension) and slow heart rate (bradycardia). It is often used because it provides sedation without affecting breathing, but careful monitoring is recommended, especially in children with conditions like obstructive sleep apnea.
12678How is the drug dexmedetomidine unique for pediatric tonsil surgery?
Dexmedetomidine is unique because it provides pain relief and sedation without causing breathing problems or increasing bleeding risk, unlike opioids or nonsteroidal anti-inflammatory drugs. It can also reduce or eliminate the need for opioids after surgery, making recovery safer for children.
12459Eligibility Criteria
This trial is for children aged 3-17 years scheduled for tonsil surgery at Boston Children's Hospital Waltham. They must be classified as ASA status I-III, indicating they are healthy or have mild to moderate systemic disease.Inclusion Criteria
American Society of Anesthesia classification status I-III
I am between 3 and 17 years old.
I am scheduled for a tonsil removal surgery at Boston Children's Hospital Waltham.
Exclusion Criteria
I have a history of chronic pain.
I am not scheduled for a tonsil removal surgery.
I have a known blood clotting disorder.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo tonsil surgery with either an opioid or opioid-sparing anesthetic plan
1 day
1 visit (in-person)
Post-operative Care
Participants are monitored in the Post-Anesthesia Care Unit for pain, nausea, and other recovery parameters
up to 8 hours
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including post-operative pain and recovery
1-2 weeks
1 follow-up call
Participant Groups
The study compares two anesthesia plans for tonsil surgeries: one uses morphine (an opioid) and the other uses dexmedetomidine (non-opioid), both combined with ketorolac and acetaminophen. It measures pain control, recovery time, and side effects like nausea and delirium.
2Treatment groups
Experimental Treatment
Active Control
Group I: Opioid-Sparing Anesthetic PlanExperimental Treatment3 Interventions
For their tonsil surgery, subjects will receive Dexmedetomidine (1mcg/kg bolus given intravenously at induction of anesthesia) and Acetaminophen (12.5mg/kg with a maximum dose of 1 gram given intravenously at induction of anesthesia). Ketorolac 0.5mg/kg with a max dose of 30mg given intravenously at the end of surgery. No opioids will be given during the procedure.
Group II: Opioid Anesthetic PlanActive Control3 Interventions
For their tonsil surgery, subjects will receive Morphine (0.1mg/kg given intravenously at induction of anesthesia) and Acetaminophen (12.5mg/kg with a maximum dose of 1 gram given intravenously at induction of anesthesia). Ketorolac 0.5mg/kg with a max dose of 30mg intravenously at the end of surgery.
Dexmedetomidine is already approved in European Union, United States, Canada, Japan for the following indications:
πͺπΊ Approved in European Union as Precedex for:
- Sedation in intensive care settings
- Procedural sedation
πΊπΈ Approved in United States as Precedex for:
- Sedation in intensive care settings
- Procedural sedation
π¨π¦ Approved in Canada as Precedex for:
- Sedation in intensive care settings
- Procedural sedation
π―π΅ Approved in Japan as Precedex for:
- Sedation in intensive care settings
- Procedural sedation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Boston Children's HospitalWaltham, MA
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Who Is Running the Clinical Trial?
Boston Children's HospitalLead Sponsor
References
The effect of intraoperative dexmedetomidine on postoperative analgesia and sedation in pediatric patients undergoing tonsillectomy and adenoidectomy. [2013]The immediate postoperative period after tonsillectomy and adenoidectomy, one of the most common pediatric surgical procedures, is often difficult. These children frequently have severe pain but postoperative airway edema along with increased sensitivity to the respiratory-depressant effects of opioids may result in obstructive symptoms and hypoxemia. Opioid consumption may be reduced by nonsteroidal antiinflammatory drugs, but these drugs may be associated with increased bleeding after this operation. Dexmedetomidine has mild analgesic properties, causes sedation without respiratory depression, and does not have an effect on coagulation. We designed a prospective, double-blind, randomized controlled study to determine the effects of intraoperative dexmedetomidine on postoperative recovery including pain, sedation, and hemodynamics in pediatric patients undergoing tonsillectomy and adenoidectomy.
Dexmedetomidine versus morphine or fentanyl in the management of children after tonsillectomy and adenoidectomy: a meta-analysis of randomized controlled trials. [2017]The primary objective of this review was to evaluate and compare the efficacy and safety of dexmedetomidine hydrochloride with the efficacy and safety of opioids for postoperative management of children after tonsillectomy and adenoidectomy.
Efficacy of dexmedetomidine for perioperative morbidities in pediatric tonsillectomy: A metaanalysis. [2018]This study aimed to assess the effects of perioperative dexmedetomidine as an adjuvant to tonsillectomy compared with opioid or sham in children.
High-dose dexmedetomidine increases the opioid-free interval and decreases opioid requirement after tonsillectomy in children. [2021]Dexmedetomidine, a selective Ξ±(2) adrenoreceptor agonist, has analgesic and sedative properties, minimal impact on respiratory parameters, and reportedly decreases analgesic requirements after surgery. Given its pharmacodynamic profile, dexmedetomidine might have a role for postoperative pain control in children undergoing tonsillectomy. In this study, we hypothesized that dexmedetomidine would delay and decrease opioid requirements after tonsillectomy.
Ketamine Enhances Intranasal Dexmedetomidine-Induced Sedation in Children: A Randomized, Double-Blind Trial. [2022]To compare the efficacy of intranasal dexmedetomidine and dexmedetomidine-ketamine premedication in preschool children undergoing tonsillectomy.
Postoperative bradycardia following adenotonsillectomy in children: Does intraoperative administration of dexmedetomidine play a role? [2018]Dexmedetomidine is a novel pharmacologic agent that has become a frequently used adjunct during care of pediatric patients with obstructive sleep apnea (OSA) undergoing tonsillectomy. While generally safe and effective, dexmedetomidine is associated with adverse effects of hypotension and bradycardia from its central sympatholytic effects. Due to safety concerns, our institution routinely admits patients with OSA for overnight cardiorespiratory monitoring following tonsillectomy. With such monitoring, we have anecdotally noted bradycardia in our patients and sought to investigate whether this was related to the increased use of intra-operative dexmedetomidine.
Dexmedetomidine use in pediatric airway reconstruction. [2022]Assess the postoperative use of dexmedetomidine (Precedex) in pediatric patients following airway reconstruction.
Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type Sedation. [2020]Dexmedetomidine (Precedex™) may be used as an alternative sedative in children, maintaining spontaneous breathing, and avoiding tracheal intubation in a non-intubated moderate or deep sedation (NI-MDS) approach. This open-label, single-arm, multicenter study evaluated the safety of dexmedetomidine in a pediatric population receiving NI-MDS in an operating room or a procedure room, with an intensivist or anesthesiologist in attendance, for elective diagnostic or therapeutic procedures expected to take at least 30 min. The primary endpoint was incidence of treatment-emergent adverse events (TEAEs). Patients received one of two doses dependent on age: patients aged ≥28 weeks' gestational age to <1 month postnatal received dose level 1 (0.1 μg/kg load; 0.05-0.2 μg/kg/h infusion); those aged 1 month to <17 years received dose level 2 (1 μg/kg load; 0.2-2.0 μg/kg/h infusion). Sedation efficacy was assessed and defined as adequate sedation for at least 80% of the time and successful completion of the procedure without the need for rescue medication. In all, 91 patients were enrolled (dose level 1, n = 1; dose level 2, n = 90); of these, 90 received treatment and 82 completed the study. Eight patients in dose level 2 discontinued treatment for the following reasons: early completion of diagnostic or therapeutic procedure (n = 3); change in medical condition (need for intubation) requiring deeper level of sedation (n = 2); adverse event (AE; hives and emesis), lack of efficacy, and physician decision (patient not sedated enough to complete procedure; n = 1 each). Sixty-seven patients experienced 147 TEAEs. The two most commonly reported AEs were respiratory depression (bradypnea; reported per protocol-defined criteria, based on absolute respiratory rate values for age or relative decrease of 30% from baseline) and hypotension. Four patients received glycopyrrolate for bradycardia and seven patients received intravenous fluids for hypotension. SpO2 dropped by 10% in two patients, but resolved without need for manual ventilation. All other reported AEs were consistent with the known safety profile of dexmedetomidine. Two of the 78 patients in the efficacy-evaluable population met all sedation efficacy criteria. Dexmedetomidine was well-tolerated in pediatric patients undergoing procedure-type sedation.
Perioperative Acetaminophen and Dexmedetomidine Eliminate Post-Operative Opioid Requirement following Pediatric Tonsillectomy. [2022]Administration of post-operative opioids following pediatric tonsillectomy can elicit respiratory events in this patient population that often arise as central and obstructive sleep apnea. The primary objective of this study was to determine whether a perioperative combination of dexmedetomidine and acetaminophen could eliminate post-operative (in recovery and at home) opioid requirements. Following IRB approval and a waiver for informed consent, the medical records of 681 patients who underwent tonsillectomy between 1 January 2013 and 31 December 2018 were evaluated. Between 1 January 2013 and 31 December 2015, all patients received a fentanyl-sevoflurane-based anesthetic, without acetaminophen or dexmedetomidine, and received opioids in recovery and for discharge home. On 1 January 2016, an institution-wide practice change replaced this protocol with a multimodal perioperative regimen of acetaminophen (intravenous or enteral) and dexmedetomidine and eliminated post-operative opioids. This is the first time that the effect of an acetaminophen and dexmedetomidine combination on the perioperative and home opioid requirement has been reported. Primarily, we compared the need for rescue opioids in the post-anesthesia care period and after discharge. The multi-modal protocol eliminated the need for post-tonsillectomy opioid administration. Dexmedetomidine in combination with acetaminophen eliminated the need for post-operative opioids in the recovery period.