Opioid-Sparing Anesthesia for Pediatric Tonsil Surgery

Overseen By Samuel Kim, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Disqualifiers: Coagulopathies, Chronic pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 day

58 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 2 6 7 8}

How 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. ^{1 2 4 5 9}

Eligibility 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.

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

Treatment Details

Interventions

• Dexmedetomidine

Trial Overview 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.

Participant Groups

Group I: Opioid-Sparing Anesthetic Plan Experimental Treatment 3 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 Plan Active Control 3 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:

Approved in European Union as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Approved in United States as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Approved in Canada as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Approved in Japan as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Findings from Research

In a study of 109 pediatric patients undergoing tonsillectomy and adenoidectomy, intraoperative dexmedetomidine (1 microg/kg) provided similar total postoperative opioid requirements as morphine (100 microg/kg), but allowed for a longer time before the first rescue analgesic was needed.

Dexmedetomidine was associated with slower heart rates in the immediate postoperative period compared to morphine, suggesting it may offer a safer alternative for pain management without respiratory depression or increased bleeding risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of intraoperative dexmedetomidine on postoperative analgesia and sedation in pediatric patients undergoing tonsillectomy and adenoidectomy. Olutoye, OA., Glover, CD., Diefenderfer, JW., et al.[2013]

Dexmedetomidine is as effective as opioids for managing postoperative pain and emergence agitation in children after tonsillectomy and adenoidectomy, based on a review of 5 trials involving 482 patients.

Patients receiving dexmedetomidine experienced a significantly shorter time to eye-opening in response to verbal stimuli compared to those receiving opioids, indicating a quicker recovery from anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine versus morphine or fentanyl in the management of children after tonsillectomy and adenoidectomy: a meta-analysis of randomized controlled trials. He, XY., Cao, JP., Shi, XY., et al.[2017]

In a review of 15 studies involving 1,552 children, perioperative dexmedetomidine significantly reduced postoperative pain and the need for analgesics compared to opioid or placebo controls during tonsillectomy.

Dexmedetomidine also decreased the incidence and severity of emergence agitation and desaturation in the postanesthesia care unit, indicating it is a safe and effective adjuvant for managing postoperative symptoms in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of dexmedetomidine for perioperative morbidities in pediatric tonsillectomy: A metaanalysis. Cho, HK., Yoon, HY., Jin, HJ., et al.[2018]

In a study involving 101 children undergoing tonsillectomy, dexmedetomidine significantly prolonged the time before they needed rescue morphine compared to fentanyl, indicating its effectiveness in reducing opioid requirements post-surgery.

Dexmedetomidine not only decreased the need for opioids but also resulted in a longer stay in the postanesthesia care unit, which may be beneficial for patients at risk of respiratory complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose dexmedetomidine increases the opioid-free interval and decreases opioid requirement after tonsillectomy in children. Pestieau, SR., Quezado, ZM., Johnson, YJ., et al.[2021]

In a study of 66 preschool children undergoing tonsillectomy, the combination of intranasal dexmedetomidine and ketamine provided significantly better sedation compared to dexmedetomidine alone, as measured by the Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S).

The combination group (dexmedetomidine and ketamine) achieved faster sedation onset (15 minutes) compared to the dexmedetomidine-only group (24 minutes), indicating that this combination may enhance preoperative comfort for young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketamine Enhances Intranasal Dexmedetomidine-Induced Sedation in Children: A Randomized, Double-Blind Trial. Qian, B., Zheng, W., Shi, J., et al.[2022]

In a study of 921 pediatric patients undergoing tonsillectomy, the use of dexmedetomidine did not show a significant association with postoperative bradycardia, as the rates were similar between those who received the drug (8.9%) and those who did not (9.4%).

The observed bradycardia was mostly asymptomatic and more likely related to factors such as older age and specific surgical procedures rather than the intra-operative administration of dexmedetomidine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative bradycardia following adenotonsillectomy in children: Does intraoperative administration of dexmedetomidine play a role? Bush, B., Tobias, JD., Lin, C., et al.[2018]

In a study of 24 pediatric patients undergoing airway reconstruction, dexmedetomidine was found to be well tolerated and safe, particularly for short-term intubation, with no significant adverse effects reported.

Dexmedetomidine may serve as a beneficial alternative to propofol for sedation during the periextubation period, allowing for easily reversible sedation, although further research is needed to explore its long-term safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine use in pediatric airway reconstruction. Silver, AL., Yager, P., Purohit, P., et al.[2022]

In a study involving 91 pediatric patients, dexmedetomidine was found to be a well-tolerated alternative sedative for non-intubated moderate or deep sedation, with a low incidence of serious adverse events.

While respiratory depression and hypotension were the most common treatment-emergent adverse events, they were manageable and consistent with dexmedetomidine's known safety profile, indicating its potential for safe use in children during elective procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type Sedation. Jooste, EH., Hammer, GB., Reyes, CR., et al.[2020]

A study of 681 pediatric patients undergoing tonsillectomy showed that using a combination of dexmedetomidine and acetaminophen eliminated the need for post-operative opioids, which can cause respiratory issues in children.

This multimodal approach not only reduced opioid requirements during recovery but also improved safety by minimizing the risk of respiratory events associated with opioid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative Acetaminophen and Dexmedetomidine Eliminate Post-Operative Opioid Requirement following Pediatric Tonsillectomy. Rudikoff, AG., Tieu, DD., Banzali, FM., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

The effect of intraoperative dexmedetomidine on postoperative analgesia and sedation in pediatric patients undergoing tonsillectomy and adenoidectomy. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Dexmedetomidine versus morphine or fentanyl in the management of children after tonsillectomy and adenoidectomy: a meta-analysis of randomized controlled trials. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy of dexmedetomidine for perioperative morbidities in pediatric tonsillectomy: A metaanalysis. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

High-dose dexmedetomidine increases the opioid-free interval and decreases opioid requirement after tonsillectomy in children. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Ketamine Enhances Intranasal Dexmedetomidine-Induced Sedation in Children: A Randomized, Double-Blind Trial. [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

Postoperative bradycardia following adenotonsillectomy in children: Does intraoperative administration of dexmedetomidine play a role? [2018]

7. England pubmed.ncbi.nlm.nih.gov

Dexmedetomidine use in pediatric airway reconstruction. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type Sedation. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Perioperative Acetaminophen and Dexmedetomidine Eliminate Post-Operative Opioid Requirement following Pediatric Tonsillectomy. [2022]