Adenoid HypertrophyPhase 2NCT03714919
A Pilot Study: a Non-opioid Technique for Postoperative Adenoidectomy Pain Relief in Pediatric Patients
A Phase 2 study testing Dextromethorphan, Acetaminophen and Dexmedetomidine in people with Adenoid Hypertrophy, run by Arlyne Thung at 1 site in United States.
Trial summary
This proposed study will assess analgesic efficacy of a multi-modal, non-opioid analgesic regimen for providing surgical analgesia in pediatric patients undergoing adenoidectomy and to assess recovery characteristics in the post-anesthesia care unit (PACU) and at home following surgery. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Adenoid Hypertrophy
- What is being tested?
- Dextromethorphan, Acetaminophen and Dexmedetomidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2019to 10 Nov 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients undergoing adenoidectomy ± bilateral ear tube placement
- Have a parent/guardian who are compliant with routine medical care, capable of subjective evaluation and able to read, understand and sign the informed consent in accordance with IRB regulations
Who cannot join
- An American Society of Anesthesiologists Physical Status ≥ 4 (severe disease that is life threatening);
- A known hypersensitivity or allergy to any of the study medications;
- A history of chronic opioid use prior to surgery;
- Coexisting renal or hepatic disease;
- Morbid obesity (BMI% ≥ 99).
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
This proposed study will assess analgesic efficacy of a multi-modal, non-opioid analgesic regimen for providing surgical analgesia in pediatric patients undergoing adenoidectomy and to assess recovery characteristics in the post-anesthesia care unit (PACU) and at home following surgery.
- Conditions
- Adenoid Hypertrophy
- Being tested
- Dextromethorphan, Acetaminophen, Dexmedetomidine, Ketamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DextromethorphanDrug
Also called Robitussin
Preoperative oral dextromethorphan 1 mg/kg
AcetaminophenDrug
Also called Tylenol
Preoperative oral acetaminophen 15 mg/kg
DexmedetomidineDrug
Also called Precedex
Intraoperative intravenous dexmedetomidine 0.5 μg/kg
KetamineDrug
Also called Ketalar
Intraoperative intravenous ketamine 0.5 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Non-opiod pain relief | Experimental | Subjects will receive preoperative oral dextromethorphan \& acetaminophen and intraoperative intravenous dexmedetomidine \& ketamine. Receives: Drug: Dextromethorphan; Drug: Acetaminophen; Drug: Dexmedetomidine; Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Pain Score
Visual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) in post-anesthesia care unit (PACU).
Measured: 1 hr post-op
Secondary outcomes (4)
Extubation Time
Amount of time in the PACU before patient is ready to be extubated.
Measured: 1 hr post-op
Time in PACU
Total time in PACU before patient met discharge criteria.
Measured: 1-2 hr post-op
Number of Participants With Sedation, Nausea/Vomiting, or Hallucinations
Presence of sedation, nausea/vomiting, or hallucinations post-operatively.
Measured: 2 hours post-op
End of Surgery to Hospital Discharge
Length of time before patient is ready to be discharged home.
Measured: 2-3 hours post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start2 Aug 2019
- Primary completion10 Nov 2019
- Study completion10 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adenoid HypertrophyStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arlyne Thung
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Arlyne Thung, Nationwide Children's Hospital
- Investigators
- Arlyne Thung, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714919
- Sponsor's protocol ID
- IRB18-00235
- Status last verified
- Jan 2021
- First submitted
- 19 Oct 2018
- Last updated
- 5 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study: a Non-opioid Technique for Postoperative Adenoidectomy Pain Relief in Pediatric Patients
- ClinicalTrials.gov ID
- NCT03714919
- Acronym / sponsor ID
- IRB18-00235
- Conditions
- Adenoid Hypertrophy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Arlyne ThungUniversity, hospital or other
- Study start
- 2 Aug 2019 (actual)
- Primary completion
- 10 Nov 2019 (actual)
- Study completion
- 10 Nov 2019 (actual)
- First posted
- 22 Oct 2018 (actual)
- Results
- Posted 5 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposed study will assess analgesic efficacy of a multi-modal, non-opioid analgesic regimen for providing surgical analgesia in pediatric patients undergoing adenoidectomy and to assess recovery characteristics in the post-anesthesia care unit (PACU) and at home following surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-opiod pain relief | Experimental | Drug: Dextromethorphan, Drug: Acetaminophen, Drug: Dexmedetomidine, Drug: KetamineSubjects will receive preoperative oral dextromethorphan \& acetaminophen and intraoperative intravenous dexmedetomidine \& ketamine. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients undergoing adenoidectomy ± bilateral ear tube placement
- Have a parent/guardian who are compliant with routine medical care, capable of subjective evaluation and able to read, understand and sign the informed consent in accordance with IRB regulations
Key exclusion criteria (5 listed)
- An American Society of Anesthesiologists Physical Status ≥ 4 (severe disease that is life threatening);
- A known hypersensitivity or allergy to any of the study medications;
- A history of chronic opioid use prior to surgery;
- Coexisting renal or hepatic disease;
- Morbid obesity (BMI% ≥ 99).
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 |
|---|---|---|
| DextromethorphanAlso: RobitussinPreoperative oral dextromethorphan 1 mg/kg | Drug | Non-opiod pain relief |
| AcetaminophenAlso: TylenolPreoperative oral acetaminophen 15 mg/kg | Drug | Non-opiod pain relief |
| DexmedetomidineAlso: PrecedexIntraoperative intravenous dexmedetomidine 0.5 μg/kg | Drug | Non-opiod pain relief |
| KetamineAlso: KetalarIntraoperative intravenous ketamine 0.5 mg/kg | Drug | Non-opiod pain relief |
Primary outcome
Average Pain Score
Time frame: 1 hr post-op
Visual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) in post-anesthesia care unit (PACU).
4 secondary outcomes
Extubation Time
Time frame: 1 hr post-op
Time in PACU
Time frame: 1-2 hr post-op
Number of Participants With Sedation, Nausea/Vomiting, or Hallucinations
Time frame: 2 hours post-op
End of Surgery to Hospital Discharge
Time frame: 2-3 hours post-op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Arlyne Thung, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dextromethorphan, Acetaminophen and Dexmedetomidine in people with Adenoid Hypertrophy, run by Arlyne Thung 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 2 inclusion and 5 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 5 Feb 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average Pain Score (time frame: 1 hr post-op). 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 5 Feb 2021; AzTrials last refreshed its copy on 30 Oct 2026.