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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two anesthesia plans for children undergoing tonsil removal to determine if one is as effective as the other while using fewer opioids. One group will receive a plan that includes dexmedetomidine (a sedative) instead of morphine, along with standard medications like ketorolac and acetaminophen for pain. The goal is to determine if the opioid-sparing plan can effectively manage pain and recovery. It is suitable for children aged 3 to 17 scheduled for tonsil surgery at Boston Children's Hospital Waltham. As an unphased trial, this study provides an opportunity to contribute to research that could enhance pain management for children undergoing surgery.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that dexmedetomidine is generally safe for children undergoing surgery. Studies have found that using dexmedetomidine during operations reduces postoperative pain and decreases the need for additional pain medication. This is particularly beneficial for avoiding opioids, which can have more serious side effects.

Dexmedetomidine has been used successfully in children for various procedures, enhancing safety. It not only alleviates pain but also reduces the likelihood of children waking up from surgery feeling confused or upset, which is crucial for a smoother recovery.

While all medications can have some side effects, evidence suggests that dexmedetomidine is a safe option for managing pain in children undergoing tonsil removal. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the opioid-sparing anesthetic approach for pediatric tonsil surgery because it uses Dexmedetomidine, a sedative that provides pain relief without the need for opioids. Unlike standard treatments that often rely on opioids like Morphine, this method aims to reduce the risk of opioid-related side effects and dependency. The combination of Dexmedetomidine with Acetaminophen and Ketorolac offers an alternative that could enhance safety and comfort for young patients during and after surgery. This approach is particularly promising as it addresses the growing concern about opioid use in children.

What evidence suggests that this trial's treatments could be effective for pediatric tonsil surgery?

Studies have shown that dexmedetomidine effectively reduces pain after tonsil surgery in children. It delays the need for pain medicine and reduces opioid use, which are strong painkillers. In this trial, one group of participants will receive an opioid-sparing anesthetic plan that includes dexmedetomidine. Research also indicates that dexmedetomidine decreases restlessness upon waking from anesthesia and improves sleep quality after surgery. These findings suggest that using dexmedetomidine as part of a plan to reduce opioid use could aid in managing pain and recovery in children after tonsil surgery. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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 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 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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12288428/

Dexmedetomidine-Based Anesthesia for Pediatric ... The study demonstrated that local infiltration with dexmedetomidine and ropivacaine significantly reduced postoperative pain in tonsillectomy ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40709118/

Dexmedetomidine-Based Anesthesia for Pediatric ... Conclusion This retrospective case series suggests that dexmedetomidine may offer a feasible opioid-sparing approach to postoperative analgesia ...

3. joma.amegroups.org joma.amegroups.org/article/view/7304/html

Analgesia for adenotonsillectomy in pediatric patients For example, dexmedetomidine prolongs time to first analgesic need, decreases emergence agitation, and reduces opioid use in children with OSA ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1089947224005562

Application of Opioid-Free Anesthesia and Analgesia Nonopioid anesthesia and analgesia regimens can improve pain scores within 48 hours after tonsillectomy in children, improve sleep quality, shorten the time to ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06326983

Opioid Sparing Anesthesia Care for Pediatric Patients ... For their tonsil surgery, subjects will receive Dexmedetomidine (1mcg/kg bolus given intravenously at induction of anesthesia) and Acetaminophen (12.5mg/kg with ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1110184911000778

Efficacy and safety of intraoperative dexmedetomidine in ... Intraoperative dexmedetomidine administration resulted in a significant reduction in pain scores postoperatively in the DEX.IV and DEX.PT groups, with no ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2794983

Effect of Intranasal Dexmedetomidine or Midazolam for ... Dexmedetomidine has been proven to be effective in reducing the occurrence of PRAEs in children with congenital heart disease, but there is no ...

8. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-025-03203-x

Effects of Intranasal dexmedetomidine and esketamine for ... Intranasal dexmedetomidine combined with esketamine for premedication was associated with reduced postoperative pain in children. It can also prevent ED and ...