A Phase 4 interventional study of Ketorolac and Dexmedetomidine in Anesthesia, Opioid Use and Tonsillitis, sponsored by Children's Hospital of Philadelphia. Terminated at 2 sites in United States. Open to participants aged 2 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-20.
Sponsored by Children's Hospital of Philadelphia · Phase 4, Interventional, and Treatment
Prospective randomized controlled trial to determine if opioid-free anesthetic for tonsillectomy is non-inferior to standard opioid-containing anesthetic
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.
103 studies on the registry are indexed under Tonsillitis; 12 are open to participants now.
This study's enrollment of 35 is below the median of 100 across 87 interventional studies indexed under Tonsillitis.
Browse Tonsillitis studies →Children's Hospital of Philadelphia is the lead sponsor of 489 studies on the registry; 90 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Morphine · Drug: Fentanyl
Opioid-Free group will receive institutional standard clinical care for tonsillectomy, without opioids, but including Dexmedetomidine and Ketorolac.
Drug: Ketorolac · Drug: Dexmedetomidine
Ketorolac (0.5mg/kg; maximum 15mg intravenously) will be given at end of procedure after evaluation for hemostasis.
Also known as: Toradol
Dexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure.
Also known as: Precedex
Morphine (0.05-0.1 mg/kg intravenously) will be given intra-operatively per institutional standard clinical care.
Fentanyl (0.5-2 ug/kg intravenously) will be given intra-operatively per institutional standard clinical care.
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.
Time frame: up to 1 hour
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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: up to post-op day 30
Number of Patients Receiving Rescue Opioids
How many subjects received rescue opioids after surgery
Time frame: 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.
Time frame: 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
Time frame: up to post-op day 30
| Milestone | Traditional Care Group (TCG) | Opioid-Free Group (OFG) |
|---|---|---|
| Started | 18 | 17 |
| Completed | 18 | 17 |
| Not completed | 0 | 0 |
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.
| score on a scale | Traditional Care Group (TCG) | Opioid-Free Group (OFG) |
|---|---|---|
| 15 minutes | 3.56 ± 3.45 | 2.47 ± 3.04 |
| 30 minutes | 2.28 ± 2.70 | 1.88 ± 2.67 |
| Nurse Max Score up to 1 hour | 5.29 ± 4.30 | 5.69 ± 4.27 |
Collected in recovery room and asked in questionnaires, collected from parents on post-operative days 1, 5, and 30.
| participants | Traditional Care Group (TCG) | Opioid-Free Group (OFG) |
|---|---|---|
| Nausea | 2 | 1 |
| Vomiting | 2 | 0 |
| pruritis | 0 | 0 |
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
| Participants | Traditional Care Group (TCG) | Opioid-Free Group (OFG) |
|---|---|---|
| Number of Participants Who Sought Unplanned Medical Attention | 1 | 3 |
Number of participants who were readmitted to the hospital by chart review and questionnaires for readmission and medical reattendance, including calls to physician.
| Participants | Traditional Care Group (TCG) | Opioid-Free Group (OFG) |
|---|---|---|
| Number of Participants Who Were Readmitted to the the Hospital | 1 | 0 |
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
| Participants | Traditional Care Group (TCG) | Opioid-Free Group (OFG) |
|---|---|---|
| Number of Participants With Non-artefactual Percentage of Oxygen Saturation (SpO2)<90% (>30 Seconds) | 1 | 1 |
How many subjects received rescue opioids after surgery
| Participants | Traditional Care Group (TCG) | Opioid-Free Group (OFG) |
|---|---|---|
| Number of Patients Receiving Rescue Opioids | 9 | 11 |
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.
| score on a scale | Traditional Care Group (TCG) | Opioid-Free Group (OFG) |
|---|---|---|
| Recovery Satisfaction | 1.4 (1 to 3) | 1.3 (1 to 3) |
| Pain Control Satisfaction | 1.6 (1 to 4) | 1.5 (1 to 3) |
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
| Participants | Traditional Care Group (TCG) | Opioid-Free Group (OFG) |
|---|---|---|
| Number of Participants That Experienced Any Post-operative Bleeding Throughout the Study | 0 | 0 |
Collected over Up to 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Traditional Care Group (TCG) | 0/18 (0%) | 2/18 (11.1%) | 4/18 (22.2%) |
| Opioid-Free Group (OFG) | 0/17 (0%) | 0/17 (0%) | 6/17 (35.3%) |
| Event | Traditional Care Group (TCG) | Opioid-Free Group (OFG) |
|---|---|---|
| Prolonged admissionGeneral disorders | 1/18 | 0/17 |
| ReadmissionGeneral disorders | 1/18 | 0/17 |
| Bleeding EventsSurgical and medical procedures | 0/18 | 0/17 |
| Event | Traditional Care Group (TCG) | Opioid-Free Group (OFG) |
|---|---|---|
| Emergency department encounterSurgical and medical procedures | 1/18 | 4/17 |
| Nausea/VomitingGastrointestinal disorders | 2/18 | 1/17 |
| Oxygen DesaturationRespiratory, thoracic and mediastinal disorders | 1/18 | 1/17 |
| DehydrationGeneral disorders | 1/18 | 1/17 |
| Age, Customized(years) | Traditional Care Group (TCG) | Opioid-Free Group (OFG) | Total |
|---|---|---|---|
| Mean | 3.56 (2 to 7) | 6.47 (3 to 13) | 4.97 (2 to 13) |
| Sex: Female, Male(Participants) | Traditional Care Group (TCG) | Opioid-Free Group (OFG) | Total |
|---|---|---|---|
| Female | 10 | 12 | 22 |
| Male | 8 | 5 | 13 |
| Race (NIH/OMB)(Participants) | Traditional Care Group (TCG) | Opioid-Free Group (OFG) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 7 | 10 |
| White | 15 | 10 | 25 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jul 2020 to primary completion in Aug 2023, 37 months.
Results were first posted in Dec 2024, 1 year 3 months after primary completion.
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Studies of the drugs tested here: Ketorolac · Dexmedetomidine
Children's Hospital of Philadelphia →