TonsillitisNCT06326983
Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery
A study testing Dexmedetomidine, Acetaminophen and Ketorolac in people with Tonsillitis and Post-operative Nausea and Vomiting (PONV), run by Boston Children's Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Tonsillitis, Post-operative Nausea and Vomiting (PONV), Emergence Delirium
- What is being tested?
- Dexmedetomidine, Acetaminophen and Ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2024to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesia classification status I-III
- Ages 3 years to 17 years
- Scheduled for tonsillectomy or tonsillotomy with or without adenoidectomy at Boston Children's Hospital Waltham
Who cannot join
- Patients not scheduled for primary tonsillectomy/tonsillotomy.
- Patients with known coagulopathies
- Patients with previous chronic pain syndromes
- Patients with any condition/indication that would prevent them from being able to be randomized (i.e. allergy to one of the study medications)
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Waltham, Massachusetts, 02453
About this study
Official title: Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery; a Randomized, Controlled, Non-inferiority Study
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.
- Conditions
- Tonsillitis, Post-operative Nausea and Vomiting (PONV), Emergence Delirium, Opioid Analgesic Adverse Reaction, Anesthesia, Pain
- Being tested
- Dexmedetomidine, Acetaminophen, Ketorolac, Morphine
- Medical subject headings
- Tonsillitis, Vomiting, Emergence Delirium, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
Dexmedetomidine (1mcg/kg bolus given intravenously at induction of anesthesia
AcetaminophenDrug
Also called Ofirmev
Acetaminophen (12.5mg/kg with a maximum dose of 1 gram given intravenously at induction of anesthesia).
KetorolacDrug
Also called Toradol
Ketorolac 0.5mg/kg with a max dose of 30mg intravenously at the end of surgery.
MorphineDrug
Morphine (0.1mg/kg given intravenously at induction of anesthesia)
| Study group | Role | What they receive |
|---|---|---|
| Opioid-Sparing Anesthetic Plan | Experimental | 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. Receives: Drug: Dexmedetomidine; Drug: Acetaminophen; Drug: Ketorolac |
| Opioid Anesthetic Plan | Active comparator | 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. Receives: Drug: Acetaminophen; Drug: Ketorolac; Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Pain Scores in the Post-Anesthesia Care Unit
Median Pain Scores in the Post-Anesthesia Care Unit measured by the numeric rating scale (NRS), Wong-Baker Faces scale or FLACC (Face, Legs, Activity, Cry, Consolability) scale as indicated based on patient age and development. All scales are done on a 0-10 point scale with 0 being no pain and 10 being the highest pain.
Measured: entry to post-anesthesia care unit to 2-6 hours post-operatively
Post-operative pain at 12-24 hours
Pain categorized as none, mild, moderate, and severe. Taken from the routine follow-up nursing phone call.
Measured: 12-24 hours post-operatively
Post Operative Anesthesia Unit Length of Stay (hours)
Length of time spent in the Post Operative Anesthesia Unit after tonsil surgery
Measured: From entry to the Post Anesthesia Care Unit to exit from the Post-Anesthesia Care Unit. Assessed for up to 8 hours on the date of surgery
Secondary outcomes (7)
Opioid rescue medication administration
Opioid rescue medications administered (reported as oral morphine equivalents)
Measured: surgery end to 2-6 hours post-operatively
Emergence Delirium
Incidence of emergence delirium defined as a score ≥ 10 on the Pediatric Anesthesia Emergence Delirium Scale. Scores range 0-20 with 0 being no agitation/delirium to 20 being the highest level.
Measured: surgery end to 2-6 hours post-operatively
Post-operative nausea and vomiting
Incidence of episodes of emesis or administration of anti-emetics in the post-anesthesia care unit
Measured: surgery end to 2-6 hours post-operatively
Procedure length (minutes)
from incision time to patient being wheeled out of the operating room
Measured: 0-60 minutes
Intraoperative Blood pressure (mmHg)
Range of systolic blood pressure within 10 minutes of anesthesia induction
Measured: 10 minutes
Intraoperative Heart rate (beats per second)
Range of heart rate within 10 minutes of anesthesia induction
Measured: 10 minutes
Vasopressor administration
Intraoperative administration of vasopressors
Measured: 0-60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start9 May 2024
- Primary completion30 Jan 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillitisStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arielle Mizrahi-Arnaud, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326983
- Sponsor's protocol ID
- IRB-P00047028
- Status last verified
- May 2026
- First submitted
- 11 Mar 2024
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery; a Randomized, Controlled, Non-inferiority Study
- ClinicalTrials.gov ID
- NCT06326983
- Acronym / sponsor ID
- IRB-P00047028
- Conditions
- Tonsillitis, Post-operative Nausea and Vomiting (PONV), Emergence Delirium, Opioid Analgesic Adverse Reaction, Anesthesia, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 9 May 2024 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid-Sparing Anesthetic Plan | Experimental | Drug: Dexmedetomidine, Drug: Acetaminophen, Drug: KetorolacFor 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. |
| Opioid Anesthetic Plan | Active comparator | Drug: Acetaminophen, Drug: Ketorolac, Drug: MorphineFor 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. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- American Society of Anesthesia classification status I-III
- Ages 3 years to 17 years
- Scheduled for tonsillectomy or tonsillotomy with or without adenoidectomy at Boston Children's Hospital Waltham
Key exclusion criteria (4 listed)
- Patients not scheduled for primary tonsillectomy/tonsillotomy.
- Patients with known coagulopathies
- Patients with previous chronic pain syndromes
- Patients with any condition/indication that would prevent them from being able to be randomized (i.e. allergy to one of the study medications)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: PrecedexDexmedetomidine (1mcg/kg bolus given intravenously at induction of anesthesia | Drug | Opioid-Sparing Anesthetic Plan |
| AcetaminophenAlso: OfirmevAcetaminophen (12.5mg/kg with a maximum dose of 1 gram given intravenously at induction of anesthesia). | Drug | Opioid Anesthetic Plan, Opioid-Sparing Anesthetic Plan |
| KetorolacAlso: ToradolKetorolac 0.5mg/kg with a max dose of 30mg intravenously at the end of surgery. | Drug | Opioid Anesthetic Plan, Opioid-Sparing Anesthetic Plan |
| MorphineMorphine (0.1mg/kg given intravenously at induction of anesthesia) | Drug | Opioid Anesthetic Plan |
Primary outcome
Median Pain Scores in the Post-Anesthesia Care Unit
Time frame: entry to post-anesthesia care unit to 2-6 hours post-operatively
Median Pain Scores in the Post-Anesthesia Care Unit measured by the numeric rating scale (NRS), Wong-Baker Faces scale or FLACC (Face, Legs, Activity, Cry, Consolability) scale as indicated based on patient age and development. All scales are done on a 0-10 point scale with 0 being no pain and 10 being the highest pain.
Post-operative pain at 12-24 hours
Time frame: 12-24 hours post-operatively
Pain categorized as none, mild, moderate, and severe. Taken from the routine follow-up nursing phone call.
Post Operative Anesthesia Unit Length of Stay (hours)
Time frame: From entry to the Post Anesthesia Care Unit to exit from the Post-Anesthesia Care Unit. Assessed for up to 8 hours on the date of surgery
Length of time spent in the Post Operative Anesthesia Unit after tonsil surgery
7 secondary outcomes
Opioid rescue medication administration
Time frame: surgery end to 2-6 hours post-operatively
Emergence Delirium
Time frame: surgery end to 2-6 hours post-operatively
Post-operative nausea and vomiting
Time frame: surgery end to 2-6 hours post-operatively
Procedure length (minutes)
Time frame: 0-60 minutes
Intraoperative Blood pressure (mmHg)
Time frame: 10 minutes
Intraoperative Heart rate (beats per second)
Time frame: 10 minutes
Vasopressor administration
Time frame: 0-60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine, Acetaminophen and Ketorolac in people with Tonsillitis and Post-operative Nausea and Vomiting (PONV), run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Pain Scores in the Post-Anesthesia Care Unit (time frame: entry to post-anesthesia care unit to 2-6 hours post-operatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.