TonsillectomyPhase 2NCT03883893
IV Acetaminophen and Post-Tonsillectomy Pain
A Phase 2 study testing Intravenous acetaminophen and Normal saline in people with Tonsillectomy and Adenoidectomy, run by Children's Hospital Medical Center, Cincinnati.
Trial summary
This study is a randomized prospective study to compare the post-operative analgesic efficacy of intravenous acetaminophen 15 mg/kg to an equal volume of 0.9% normal saline when all other analgesic interventions have been standardized for all patients enrolled. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Tonsillectomy, Adenoidectomy
- What is being tested?
- Intravenous acetaminophen and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2021to Apr 2023
- Phase
- Phase 2
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The subject is age 3 to 10 years (inclusive)
- The subject weighs more than 10.0 kg (inclusive of the tenth kilogram)
- The subject is scheduled for the following: Elective tonsillectomy or tonsillectomy with adenoidectomy scheduled on an outpatient basis, with acceptable inclusion of patients also having PETs and/or EUA of ear
- The subject is ASA patient classification I-II
- The subject's legally authorized representative has given written informed consent to participate in the study and when appropriate, the subject has given assent or consent to participate.
Who cannot join
- Additional surgical procedures are being performed concurrently;
- The subject is ASA classification > II;
- The subject has pre-existing allergy or known hypersensitivity to acetaminophen;
- The subject receives midazolam as a premedication;
- The subject has a history of chronic malnutrition;
- The subject has any other condition, which in the opinion of the principal investigator, would not be suitable for participation in the study
About this study
Official title: Randomized Prospective Study Investigating the Analgesic Efficacy of Intravenous Acetaminophen in Reducing Post-Tonsillectomy Pain in Pediatric Patients
This study is a randomized prospective study to compare the post-operative analgesic efficacy of intravenous acetaminophen 15 mg/kg to an equal volume of 0.9% normal saline when all other analgesic interventions have been standardized for all patients enrolled.
- Conditions
- Tonsillectomy, Adenoidectomy
- Being tested
- Intravenous acetaminophen, Normal saline
- Keywords
- Tonsillectomy, Intravenous Acetaminophen, Pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous acetaminophenDrug
Also called IV Tylenol
Intravenous acetaminophen will be given in the OR.
Normal salineOther
Normal saline will given if randomized to this group.
| Study group | Role | What they receive |
|---|---|---|
| IV Tylenol | Active comparator | Participants will receive IV acetaminophen 15mg/kg in the OR. Receives: Drug: Intravenous acetaminophen |
| Normal Saline | Placebo comparator | Participants will receive 0.9% normal saline in the OR. The amount received will be equivalent of what would be given if they were receiving IV acetaminophen. Receives: Other: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain scores
FLACC (Face, Legs, Activity, Cry, Consolability) behavior scale Each area measured is graded 0 - 2 and then totaled. Total score will range from 0 - 10. A total score of 0 - patient is relaxed and comfortable, 1 - 3 - patient is mildly uncomfortable, 4 - 6 - patient is in moderate pain, 7 - 10 - patient is having severe discomfort/pain
Measured: Every 5 minutes after awake in recovery room for 30 minutes
Secondary outcomes (1)
Quality of emergence from anesthesia
Pediatric Anesthesia Emergence Delirium scale (PAED)
This scale uses 5 criteria to determine the extent of emergence delirium in children. "The child makes eye contact with the caregiver", "The child's actions are purposeful", The child is aware of his/her surroundings", The child is restless" and "The child is inconsolable." Each of these 5 catagories are scored on a 0-4 scale. The higher the total number the greater the extent of the emergence delirium.
Measured: When first spontaneous eye movement occurs in recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study startDec 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionApr 2023 (estimated)
Why it stopped: Mentor for PI left institution. Study was not renewed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillectomyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judy Audas, APRN-CRNA,MSN, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883893
- Sponsor's protocol ID
- 2018-0565
- Status last verified
- Mar 2022
- First submitted
- 19 Mar 2019
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Study Investigating the Analgesic Efficacy of Intravenous Acetaminophen in Reducing Post-Tonsillectomy Pain in Pediatric Patients
- ClinicalTrials.gov ID
- NCT03883893
- Acronym / sponsor ID
- 2018-0565
- Conditions
- Tonsillectomy, Adenoidectomy
- Keywords
- Tonsillectomy, Intravenous Acetaminophen, Pediatric
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Mentor for PI left institution. Study was not renewed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 21 Mar 2019 (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 study is a randomized prospective study to compare the post-operative analgesic efficacy of intravenous acetaminophen 15 mg/kg to an equal volume of 0.9% normal saline when all other analgesic interventions have been standardized for all patients enrolled.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV Tylenol | Active comparator | Drug: Intravenous acetaminophenParticipants will receive IV acetaminophen 15mg/kg in the OR. |
| Normal Saline | Placebo comparator | Other: Normal salineParticipants will receive 0.9% normal saline in the OR. The amount received will be equivalent of what would be given if they were receiving IV acetaminophen. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- The subject is age 3 to 10 years (inclusive)
- The subject weighs more than 10.0 kg (inclusive of the tenth kilogram)
- The subject is scheduled for the following: Elective tonsillectomy or tonsillectomy with adenoidectomy scheduled on an outpatient basis, with acceptable inclusion of patients also having PETs and/or EUA of ear
- The subject is ASA patient classification I-II
- The subject's legally authorized representative has given written informed consent to participate in the study and when appropriate, the subject has given assent or consent to participate.
Key exclusion criteria (6 listed)
- Additional surgical procedures are being performed concurrently;
- The subject is ASA classification > II;
- The subject has pre-existing allergy or known hypersensitivity to acetaminophen;
- The subject receives midazolam as a premedication;
- The subject has a history of chronic malnutrition;
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 |
|---|---|---|
| Intravenous acetaminophenAlso: IV TylenolIntravenous acetaminophen will be given in the OR. | Drug | IV Tylenol |
| Normal salineNormal saline will given if randomized to this group. | Other | Normal Saline |
Primary outcome
Post-operative pain scores
Time frame: Every 5 minutes after awake in recovery room for 30 minutes
FLACC (Face, Legs, Activity, Cry, Consolability) behavior scale Each area measured is graded 0 - 2 and then totaled. Total score will range from 0 - 10. A total score of 0 - patient is relaxed and comfortable, 1 - 3 - patient is mildly uncomfortable, 4 - 6 - patient is in moderate pain, 7 - 10 - patient is having severe discomfort/pain
1 secondary outcome
Quality of emergence from anesthesia
Time frame: When first spontaneous eye movement occurs in recovery room
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
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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.
Judy Audas, APRN-CRNA,MSN principal investigator
Children's Hospital Medical Center, Cincinnati
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravenous acetaminophen and Normal saline in people with Tonsillectomy and Adenoidectomy, run by Children's Hospital Medical Center, Cincinnati.
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 5 inclusion and 6 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: withdrawn, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Post-operative pain scores (time frame: Every 5 minutes after awake in recovery room for 30 minutes). 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 Apr 2022.