AnesthesiaPhase 4NCT04528173
Opioid-Free Anesthetic for Tonsillectomy
A Phase 4 study testing Ketorolac, Dexmedetomidine and Morphine in people with Anesthesia and Opioid Use, run by Children's Hospital of Philadelphia at 2 sites in United States.
Trial summary
Prospective randomized controlled trial to determine if opioid-free anesthetic for tonsillectomy is non-inferior to standard opioid-containing anesthetic Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Opioid Use, Tonsillitis
- What is being tested?
- Ketorolac, Dexmedetomidine and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Jul 2020to 22 Aug 2023
- Phase
- Phase 4
- 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 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Males or females age 2 to 18 years.
- American Society of Anesthesiologists {ASA) ≤ 3 physical classification system
- Girls after menarche must have a negative pregnancy test.
- Scheduled tonsillectomy or tonsillectomy combined with adenoidectomy and/or ear tube placement at the Children's Hospital of Philadelphia (CHOP) main or ambulatory surgical centers.
- Parental/guardian permission (informed consent) and if appropriate, child assent
Who cannot join
- Current (Within the last 30 days) opioid use for pain control
- High risk for surgical site hemorrhage, determined by bleeding disorder diagnosis or evidence or poor hemostasis
- Multiple scheduled surgeries at the same time other than adenoidectomy and/or ear tube placement
- History of drug abuse, chronic pain, bleeding disorder
- Chronic disease such as sickle cell disease for which treatment with opioids may be clinically indicated
- Significant congenital disorders, medication allergies or comorbidities, specifically a pre-disposition to bradycardia or conduction abnormalities, cyanotic cardiac disease and use of medications that would increase risk of bleeding or bradycardia.
Show all 14Show fewer
- History of hepatic dysfunction, renal dysfunction, thrombocytopenia, or anemia (including pre-surgery laboratory abnormalities)
- History of hypersensitivity to NSAIDs
- Patients with asthma, including patients who have experienced aspirin- or NSAID-sensitive asthma or a history of exacerbation when aspirin or NSAIDs are administered (e.g. bronchospasm, urticaria, etc.)
- Subjects receiving medications that could impact metabolism of either study drug should also be excluded
- Trisomy 21 diagnosis
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
- Patients on a Ketogenic diet
- Parents or subjects who do not speak English
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Tennessee Health Science Center; St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Opioid-Free Versus Transitional Anesthetic With Opioids From Tonsillectomy
Prospective randomized controlled trial to determine if opioid-free anesthetic for tonsillectomy is non-inferior to standard opioid-containing anesthetic
Read the detailed description
Objectives:
Primary: To determine if an opioid-free anesthetic provides equivalent acute postoperative pain relief in tonsillectomy.
Secondary: To determine if post-operative pain at home is not significantly different with an opioid-free regimen compared to an opioid containing regimen for tonsillectomy.
Study Design: Prospective, randomized, multi-center trial study
Study Interventions and Measures:
Subject will be randomized to 1:1 intra-operative opioid-free (OFG) vs traditional care anesthetic with opioids (TCG) group
The primary endpoint is the median pain score (calculated by a blinded validated observer in the recovery room at two time intervals) between the two cohorts.
- Conditions
- Anesthesia, Opioid Use, Tonsillitis, Sleep Disorder, Surgery
- Being tested
- Ketorolac, Dexmedetomidine, Morphine, Fentanyl
- Keywords
- Tonsillectomy, Opioid-Free, Ketorolac, Dexmedetomidine, Acute postoperative pain relief, Opioid, Morphine, Fentanyl
- Medical subject headings
- Tonsillitis, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
Also called Toradol
Ketorolac (0.5mg/kg; maximum 15mg intravenously) will be given at end of procedure after evaluation for hemostasis.
DexmedetomidineDrug
Also called Precedex
Dexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure.
MorphineDrug
Morphine (0.05-0.1 mg/kg intravenously) will be given intra-operatively per institutional standard clinical care.
FentanylDrug
Fentanyl (0.5-2 ug/kg intravenously) will be given intra-operatively per institutional standard clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Care Group (TCG) | Active comparator | Traditional anesthetic with opioids group will receive institutional standard clinical care for tonsillectomy, including a standardized opioid dose at the beginning of the case and again at the end if needed. Dexmedetomidine and Ketorolac will not be used intra-operatively in this cohort to prevent confounding. Receives: Drug: Morphine; Drug: Fentanyl |
| Opioid-Free Group (OFG) | Experimental | Opioid-Free group will receive institutional standard clinical care for tonsillectomy, without opioids, but including Dexmedetomidine and Ketorolac. Receives: Drug: Ketorolac; Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean FLACC (Face, Legs, Activity, Cry, Consolability) Pain Score
Mean FLACC pain assessment scores are calculated 15 and 30 minutes after awakening, Scores are calculated by a blinded study team observer. Minimum Score: 0 and Maximum Score: 10. Higher scores indicate worse outcomes.
One Nursing Maximum FLACC pain score is obtained by an unblinded patient Registered Nurse (RN) during the patient's Post-Anesthesia Care Unit (PACU) stay within one hour of awakening. The pain score is collected from the nursing documentation in the electronic medical record. FLACC Minimum Score: 0 and Maximum Score: 10 Higher scores indicate worse outcomes.
Measured: up to 1 hour
Secondary outcomes (7)
Number of Participants With Nausea, Vomiting, Pruritis
Collected in recovery room and asked in questionnaires, collected from parents on post-operative days 1, 5, and 30.
Measured: up to post-op day 30
Number of Participants Who Sought Unplanned Medical Attention
Number of participants who were readmitted to the hospital and sought unplanned medical attention (phone calls, office visits, emergency department visits) by chart review and questionnaires for readmission and medical reattendance, including calls to physician
Measured: up to post-op day 30
Number of Participants Who Were Readmitted to the the Hospital
Number of participants who were readmitted to the hospital by chart review and questionnaires for readmission and medical reattendance, including calls to physician.
Measured: Up to post-op day 30
Number of Participants With Non-artefactual Percentage of Oxygen Saturation (SpO2)<90% (>30 Seconds)
Number of participants with non-artefactual percentage of oxygen saturation (SpO2) less than 90% for greater than 30 seconds). Collected in the recovery room and chart review
Measured: up to post-op day 30
Number of Patients Receiving Rescue Opioids
How many subjects received rescue opioids after surgery
Measured: up to post-op day 30
Family Satisfaction With Patient Recovery Based on Five-point Likert Score
Follow-up questionnaire to family on post-op days 1, 5, and 30. Parents will be asked to rank how satisfied they are with their child's recovery by using these two prompts: "I am satisfied with my child's recovery," and "I am satisfied with my child's pain control at home." They will choose from the following options: "Strongly agree = 1", "Agree = 2", "Undecided = 3", "Disagree = 4", "Strongly Disagree =5." Minimum score is 1, Max is 5. Higher scores indicate worse outcomes. Data assessed at post-op days 1, 5, and 30 were averaged.
Measured: assessed at post-op days 1, 5, and 30
Number of Participants That Experienced Any Post-operative Bleeding Throughout the Study
Follow-up questionnaires administered on post-operative day 1, 5, ad 30 and chart review.
Question: Has your child had any bright red blood in their mouth? Answer options: Yes/No
Measured: up to post-op day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start22 Jul 2020
- Primary completion22 Aug 2023
- Study completion22 Aug 2023
Why it stopped: Difficulty with enrollment
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.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subject will be randomized to 1:1 intra-operative opioid-free (OFG) vs traditional care anesthetic with opioids (TCG) group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, University of Tennessee
- Responsible party
- Sponsor
- Investigators
- Tori Sutherland, MD,MPH, Principal investigator, Children's Hospital of PhiladelphiaAnthony Sheyn, MD, FACS, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528173
- Sponsor's protocol ID
- 19-016618
- Status last verified
- Dec 2024
- First submitted
- 28 Jul 2020
- Last updated
- 20 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Volkow ND, Jones EB, Einstein EB, Wargo EM. Prevention and Treatment of Opioid Misuse and Addiction: A Review. JAMA Psychiatry. 2019 Feb 1;76(2):208-216. doi: 10.1001/jamapsychiatry.2018.3126.
PubMed 30516809Scholl L, Seth P, Kariisa M, Wilson N, Baldwin G. Drug and Opioid-Involved Overdose Deaths - United States, 2013-2017. MMWR Morb Mortal Wkly Rep. 2018 Jan 4;67(5152):1419-1427. doi: 10.15585/mmwr.mm675152e1.
PubMed 30605448Harbaugh CM, Lee JS, Hu HM, McCabe SE, Voepel-Lewis T, Englesbe MJ, Brummett CM, Waljee JF. Persistent Opioid Use Among Pediatric Patients After Surgery. Pediatrics. 2018 Jan;141(1):e20172439. doi: 10.1542/peds.2017-2439. Epub 2017 Dec 4.
PubMed 29203521Harbaugh CM, Nalliah RP, Hu HM, Englesbe MJ, Waljee JF, Brummett CM. Persistent Opioid Use After Wisdom Tooth Extraction. JAMA. 2018 Aug 7;320(5):504-506. doi: 10.1001/jama.2018.9023.
PubMed 30088000Kelly LE, Sommer DD, Ramakrishna J, Hoffbauer S, Arbab-Tafti S, Reid D, Maclean J, Koren G. Morphine or Ibuprofen for post-tonsillectomy analgesia: a randomized trial. Pediatrics. 2015 Feb;135(2):307-13. doi: 10.1542/peds.2014-1906.
PubMed 25624387Franz AM, Dahl JP, Huang H, Verma ST, Martin LD, Martin LD, Low DK. The development of an opioid sparing anesthesia protocol for pediatric ambulatory tonsillectomy and adenotonsillectomy surgery-A quality improvement project. Paediatr Anaesth. 2019 Jul;29(7):682-689. doi: 10.1111/pan.13662. Epub 2019 Jun 19.
PubMed 31077491Frauenknecht J, Kirkham KR, Jacot-Guillarmod A, Albrecht E. Analgesic impact of intra-operative opioids vs. opioid-free anaesthesia: a systematic review and meta-analysis. Anaesthesia. 2019 May;74(5):651-662. doi: 10.1111/anae.14582. Epub 2019 Feb 25.
PubMed 30802933Elkassabany NM, Mariano ER. Opioid-free anaesthesia - what would Inigo Montoya say? Anaesthesia. 2019 May;74(5):560-563. doi: 10.1111/anae.14611. Epub 2019 Feb 25. No abstract available.
PubMed 30802930Mitchell RB, Archer SM, Ishman SL, Rosenfeld RM, Coles S, Finestone SA, Friedman NR, Giordano T, Hildrew DM, Kim TW, Lloyd RM, Parikh SR, Shulman ST, Walner DL, Walsh SA, Nnacheta LC. Clinical Practice Guideline: Tonsillectomy in Children (Update). Otolaryngol Head Neck Surg. 2019 Feb;160(1_suppl):S1-S42. doi: 10.1177/0194599818801757.
PubMed 30798778Baugh RF, Archer SM, Mitchell RB, Rosenfeld RM, Amin R, Burns JJ, Darrow DH, Giordano T, Litman RS, Li KK, Mannix ME, Schwartz RH, Setzen G, Wald ER, Wall E, Sandberg G, Patel MM; American Academy of Otolaryngology-Head and Neck Surgery Foundation. Clinical practice guideline: tonsillectomy in children. Otolaryngol Head Neck Surg. 2011 Jan;144(1 Suppl):S1-30. doi: 10.1177/0194599810389949.
PubMed 21493257Cote CJ, Posner KL, Domino KB. Death or neurologic injury after tonsillectomy in children with a focus on obstructive sleep apnea: houston, we have a problem! Anesth Analg. 2014 Jun;118(6):1276-83. doi: 10.1213/ANE.0b013e318294fc47.
PubMed 23842193McCabe SE, Schulenberg JE, O'Malley PM, Patrick ME, Kloska DD. Non-medical use of prescription opioids during the transition to adulthood: a multi-cohort national longitudinal study. Addiction. 2014 Jan;109(1):102-10. doi: 10.1111/add.12347. Epub 2013 Oct 22.
PubMed 24025114McCabe SE, West BT, Boyd CJ. Medical use, medical misuse, and nonmedical use of prescription opioids: results from a longitudinal study. Pain. 2013 May;154(5):708-713. doi: 10.1016/j.pain.2013.01.011. Epub 2013 Jan 26.
PubMed 23433943McCabe SE, West BT, Boyd CJ. Leftover prescription opioids and nonmedical use among high school seniors: a multi-cohort national study. J Adolesc Health. 2013 Apr;52(4):480-5. doi: 10.1016/j.jadohealth.2012.08.007. Epub 2012 Nov 22.
PubMed 23298996Winters KC, Arria A. Adolescent Brain Development and Drugs. Prev Res. 2011;18(2):21-24.
PubMed 22822298
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid-Free Versus Transitional Anesthetic With Opioids From Tonsillectomy
- ClinicalTrials.gov ID
- NCT04528173
- Acronym / sponsor ID
- 19-016618
- Conditions
- Anesthesia, Opioid Use, Tonsillitis, Sleep Disorder, Surgery
- Keywords
- Tonsillectomy, Opioid-Free, Ketorolac, Dexmedetomidine, Acute postoperative pain relief, Opioid, Morphine, Fentanyl
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty with enrollment
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- University of Pennsylvania, University of Tennessee
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- 22 Aug 2023 (actual)
- Study completion
- 22 Aug 2023 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Posted 20 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective randomized controlled trial to determine if opioid-free anesthetic for tonsillectomy is non-inferior to standard opioid-containing anesthetic
Detailed description
Objectives:
Primary: To determine if an opioid-free anesthetic provides equivalent acute postoperative pain relief in tonsillectomy.
Secondary: To determine if post-operative pain at home is not significantly different with an opioid-free regimen compared to an opioid containing regimen for tonsillectomy.
Study Design: Prospective, randomized, multi-center trial study
Study Interventions and Measures:
Subject will be randomized to 1:1 intra-operative opioid-free (OFG) vs traditional care anesthetic with opioids (TCG) group
The primary endpoint is the median pain score (calculated by a blinded validated observer in the recovery room at two time intervals) between the two cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subject will be randomized to 1:1 intra-operative opioid-free (OFG) vs traditional care anesthetic with opioids (TCG) group.
| Arm | Type | Receives |
|---|---|---|
| Traditional Care Group (TCG) | Active comparator | Drug: Morphine, Drug: FentanylTraditional anesthetic with opioids group will receive institutional standard clinical care for tonsillectomy, including a standardized opioid dose at the beginning of the case and again at the end if needed. Dexmedetomidine and Ketorolac will not be used intra-operatively in this cohort to prevent confounding. |
| Opioid-Free Group (OFG) | Experimental | Drug: Ketorolac, Drug: DexmedetomidineOpioid-Free group will receive institutional standard clinical care for tonsillectomy, without opioids, but including Dexmedetomidine and Ketorolac. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Males or females age 2 to 18 years.
- American Society of Anesthesiologists {ASA) ≤ 3 physical classification system
- Girls after menarche must have a negative pregnancy test.
- Scheduled tonsillectomy or tonsillectomy combined with adenoidectomy and/or ear tube placement at the Children's Hospital of Philadelphia (CHOP) main or ambulatory surgical centers.
- Parental/guardian permission (informed consent) and if appropriate, child assent
Key exclusion criteria (14 listed)
- Current (Within the last 30 days) opioid use for pain control
- High risk for surgical site hemorrhage, determined by bleeding disorder diagnosis or evidence or poor hemostasis
- Multiple scheduled surgeries at the same time other than adenoidectomy and/or ear tube placement
- History of drug abuse, chronic pain, bleeding disorder
- Chronic disease such as sickle cell disease for which treatment with opioids may be clinically indicated
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 |
|---|---|---|
| KetorolacAlso: ToradolKetorolac (0.5mg/kg; maximum 15mg intravenously) will be given at end of procedure after evaluation for hemostasis. | Drug | Opioid-Free Group (OFG) |
| DexmedetomidineAlso: PrecedexDexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure. | Drug | Opioid-Free Group (OFG) |
| MorphineMorphine (0.05-0.1 mg/kg intravenously) will be given intra-operatively per institutional standard clinical care. | Drug | Traditional Care Group (TCG) |
| FentanylFentanyl (0.5-2 ug/kg intravenously) will be given intra-operatively per institutional standard clinical care. | Drug | Traditional Care Group (TCG) |
Primary outcome
Mean FLACC (Face, Legs, Activity, Cry, Consolability) Pain Score
Time frame: up to 1 hour
Mean FLACC pain assessment scores are calculated 15 and 30 minutes after awakening, Scores are calculated by a blinded study team observer. Minimum Score: 0 and Maximum Score: 10. Higher scores indicate worse outcomes. One Nursing Maximum FLACC pain score is obtained by an unblinded patient Registered Nurse (RN) during the patient's Post-Anesthesia Care Unit (PACU) stay within one hour of awakening. The pain score is collected from the nursing documentation in the electronic medical record. FLACC Minimum Score: 0 and Maximum Score: 10 Higher scores indicate worse outcomes.
7 secondary outcomes
Number of Participants With Nausea, Vomiting, Pruritis
Time frame: up to post-op day 30
Number of Participants Who Sought Unplanned Medical Attention
Time frame: up to post-op day 30
Number of Participants Who Were Readmitted to the the Hospital
Time frame: Up to post-op day 30
Number of Participants With Non-artefactual Percentage of Oxygen Saturation (SpO2)<90% (>30 Seconds)
Time frame: up to post-op day 30
Number of Patients Receiving Rescue Opioids
Time frame: up to post-op day 30
Family Satisfaction With Patient Recovery Based on Five-point Likert Score
Time frame: assessed at post-op days 1, 5, and 30
Number of Participants That Experienced Any Post-operative Bleeding Throughout the Study
Time frame: up to post-op day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30516809Volkow ND, Jones EB, Einstein EB, Wargo EM. Prevention and Treatment of Opioid Misuse and Addiction: A Review. JAMA Psychiatry. 2019 Feb 1;76(2):208-216. doi: 10.1001/jamapsychiatry.2018.3126.
- Background: PubMed 30605448Scholl L, Seth P, Kariisa M, Wilson N, Baldwin G. Drug and Opioid-Involved Overdose Deaths - United States, 2013-2017. MMWR Morb Mortal Wkly Rep. 2018 Jan 4;67(5152):1419-1427. doi: 10.15585/mmwr.mm675152e1.
- Background: PubMed 29203521Harbaugh CM, Lee JS, Hu HM, McCabe SE, Voepel-Lewis T, Englesbe MJ, Brummett CM, Waljee JF. Persistent Opioid Use Among Pediatric Patients After Surgery. Pediatrics. 2018 Jan;141(1):e20172439. doi: 10.1542/peds.2017-2439. Epub 2017 Dec 4.
- Background: PubMed 30088000Harbaugh CM, Nalliah RP, Hu HM, Englesbe MJ, Waljee JF, Brummett CM. Persistent Opioid Use After Wisdom Tooth Extraction. JAMA. 2018 Aug 7;320(5):504-506. doi: 10.1001/jama.2018.9023.
- Background: PubMed 25624387Kelly LE, Sommer DD, Ramakrishna J, Hoffbauer S, Arbab-Tafti S, Reid D, Maclean J, Koren G. Morphine or Ibuprofen for post-tonsillectomy analgesia: a randomized trial. Pediatrics. 2015 Feb;135(2):307-13. doi: 10.1542/peds.2014-1906.
- Background: PubMed 31077491Franz AM, Dahl JP, Huang H, Verma ST, Martin LD, Martin LD, Low DK. The development of an opioid sparing anesthesia protocol for pediatric ambulatory tonsillectomy and adenotonsillectomy surgery-A quality improvement project. Paediatr Anaesth. 2019 Jul;29(7):682-689. doi: 10.1111/pan.13662. Epub 2019 Jun 19.
- Background: PubMed 30802933Frauenknecht J, Kirkham KR, Jacot-Guillarmod A, Albrecht E. Analgesic impact of intra-operative opioids vs. opioid-free anaesthesia: a systematic review and meta-analysis. Anaesthesia. 2019 May;74(5):651-662. doi: 10.1111/anae.14582. Epub 2019 Feb 25.
- Background: PubMed 30802930Elkassabany NM, Mariano ER. Opioid-free anaesthesia - what would Inigo Montoya say? Anaesthesia. 2019 May;74(5):560-563. doi: 10.1111/anae.14611. Epub 2019 Feb 25. No abstract available.
- Background: PubMed 30798778Mitchell RB, Archer SM, Ishman SL, Rosenfeld RM, Coles S, Finestone SA, Friedman NR, Giordano T, Hildrew DM, Kim TW, Lloyd RM, Parikh SR, Shulman ST, Walner DL, Walsh SA, Nnacheta LC. Clinical Practice Guideline: Tonsillectomy in Children (Update). Otolaryngol Head Neck Surg. 2019 Feb;160(1_suppl):S1-S42. doi: 10.1177/0194599818801757.
- Background: PubMed 21493257Baugh RF, Archer SM, Mitchell RB, Rosenfeld RM, Amin R, Burns JJ, Darrow DH, Giordano T, Litman RS, Li KK, Mannix ME, Schwartz RH, Setzen G, Wald ER, Wall E, Sandberg G, Patel MM; American Academy of Otolaryngology-Head and Neck Surgery Foundation. Clinical practice guideline: tonsillectomy in children. Otolaryngol Head Neck Surg. 2011 Jan;144(1 Suppl):S1-30. doi: 10.1177/0194599810389949.
- Background: PubMed 23842193Cote CJ, Posner KL, Domino KB. Death or neurologic injury after tonsillectomy in children with a focus on obstructive sleep apnea: houston, we have a problem! Anesth Analg. 2014 Jun;118(6):1276-83. doi: 10.1213/ANE.0b013e318294fc47.
- Background: PubMed 24025114McCabe SE, Schulenberg JE, O'Malley PM, Patrick ME, Kloska DD. Non-medical use of prescription opioids during the transition to adulthood: a multi-cohort national longitudinal study. Addiction. 2014 Jan;109(1):102-10. doi: 10.1111/add.12347. Epub 2013 Oct 22.
- Key substance use and mental health indicators in the United States: Results from the 2016 National Survey on Drug Use and Health (HHS Publication No. SMA 17-5044). Center fLink provided by the sponsor.
- Sealed Envelope Ltd. 2012. Power calculator for continuous outcome non-inferiority trial.Link provided by the sponsor.
- Buck, ML. Use of Intravenous Ketorolac for Postoperative Analgesia in Infants: Pediatric Pharmacotherapy, A Monthly Newsletter. . 2011Link provided by the sponsor.
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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.
Tori Sutherland, MD,MPH principal investigator
Children's Hospital of Philadelphia
Anthony Sheyn, MD, FACS principal investigator
University of Tennessee
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketorolac, Dexmedetomidine and Morphine in people with Anesthesia and Opioid Use, run by Children's Hospital of Philadelphia at 2 sites 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 5 inclusion and 14 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: stopped early, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 20 Dec 2024). 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?
Mean FLACC (Face, Legs, Activity, Cry, Consolability) Pain Score (time frame: up to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04528173, which also lists 34 linked publications.
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 20 Dec 2024.