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Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04230681
Recruitment Status : Suspended (Temporarily paused due to COVID-19 and expected to resume. This is not a suspension of IRB approval.)
First Posted : January 18, 2020
Last Update Posted : May 7, 2020
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
A RCT to compare hydromorphone versus fentanyl for pain control following tonsillectomy or adenotonsillectomy surgery.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Tonsillitis Drug: Hydromorphone Drug: Fentanyl Early Phase 1

Detailed Description:
This is a randomized clinical trial with masked assessment, comparing recovery indices for patients receiving intermediate acting versus short acting opioid analgesia using hydromorphone or fentanyl as intraoperative analgesics. An otherwise standardized anesthetic and analgesic regimen will be utilized, consistent with routine care at SLCH. Patients will be randomized 1:1 in block sizes of 5 per group. Patients will be randomized to receive either hydromorphone or fentanyl throughout the perioperative period by opening a sealed protocol envelope.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial to Compare Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery
Actual Study Start Date : February 26, 2020
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

Arm Intervention/treatment
Active Comparator: Fentanyl Drug: Fentanyl
Fentanyl

Active Comparator: Hydromorphone Drug: Hydromorphone
Patients will be randomized to one of two opioids for the treatment of post-operative pain.




Primary Outcome Measures :
  1. Amount of rescue opioid medications administered - hydromorphone group [ Time Frame: up to 48 hours post surgery ]
    Postoperative opioid medication expressed in morphine equivalents

  2. Amount of rescue opioid medications administered - fentanyl group [ Time Frame: up to 48 hours post surgery ]
    Postoperative opioid medication expressed in morphine equivalents

  3. Evaluation of participant's pain - hydromorphone group [ Time Frame: up to 48 hours post surgery ]
    Revised Face, Legs, Activity, Cry, Consolability (rFLACC) Scale Each of the five categories (F) Face; (L) Legs; (A) Activity; (C) Cry; (C) Consolability is scored from 0-2, which results in a total score between zero and ten. 0=no pain/relaxed, 10=distressed/in pain

  4. Evaluation of participant's pain - fentanyl group [ Time Frame: up to 48 hours post surgery ]
    Revised Face, Legs, Activity, Cry, Consolability (rFLACC) Scale Each of the five categories (F) Face; (L) Legs; (A) Activity; (C) Cry; (C) Consolability is scored from 0-2, which results in a total score between zero and ten. 0=no pain/relaxed, 10=distressed/in pain


Secondary Outcome Measures :
  1. Preoperative Amsterdam Preoperative Anxiety Scale - hydromorphone group [ Time Frame: up to 12 hours prior to surgery ]

    Caregiver of the participant is asked questions regarding the child's anxiety level prior to surgery. The questions asked: 1) I am worried about the anesthetic, 2) The anesthetic is on my mind continually, 3) I would like to know as much as possible about the anesthetic, 4) I am worried about the procedure, 5) The procedure is on my mind continually, 6) I would like to know as much as possible about the procedure

    The measure of agreement with these statements should be graded on a 5-point Likert scale from 1 "not at all" to 5 "extremely." A score of ≥11 identify anxious patients in clinical practice.


  2. Preoperative Amsterdam Preoperative Anxiety Scale - fentanyl group [ Time Frame: up to 12 hours prior to surgery ]

    Caregiver of the participant is asked questions regarding the child's anxiety level prior to surgery. The questions asked: 1) I am worried about the anesthetic, 2) The anesthetic is on my mind continually, 3) I would like to know as much as possible about the anesthetic, 4) I am worried about the procedure, 5) The procedure is on my mind continually, 6) I would like to know as much as possible about the procedure

    The measure of agreement with these statements should be graded on a 5-point Likert scale from 1 "not at all" to 5 "extremely." A score of ≥11 identify anxious patients in clinical practice.


  3. Yale Preoperative Anxiety Scale - hydromorphone group [ Time Frame: up to 12 hours prior to surgery ]
    Assessing child anxiety during the induction of anesthesia. It contains 22 items in 5 categories: activity, emotional expressivity, state of arousal, vocalization, and use of parents. Each category receives a score on a scale of 0 to 4 (6 for vocalization) according to the behavior of the patient, with 0 = no anxiety and 4 (or 6 for vocalization) = high anxiety.

  4. Yale Preoperative Anxiety Scale - fentanyl group [ Time Frame: up to 12 hours prior to surgery ]
    Assessing child anxiety during the induction of anesthesia. It contains 22 items in 5 categories: activity, emotional expressivity, state of arousal, vocalization, and use of parents. Each category receives a score on a scale of 0 to 4 (6 for vocalization) according to the behavior of the patient, with 0 = no anxiety and 4 (or 6 for vocalization) = high anxiety.

  5. ASA physical status classification score from preoperative assessment - hydromorphone group [ Time Frame: up to 12 hours prior to surgery ]
    ASA I A normal healthy patient ASA II A patient with mild systemic disease ASA III A patient with severe systemic disease ASA IV A patient with severe systemic disease that is a constant threat to life ASA V A moribund patient who is not expected to survive without the operation ASA VI A declared brain-dead patient whose organs are being removed for donor purposes

  6. ASA physical status classification score from preoperative assessment - fentanyl group [ Time Frame: up to 12 hours prior to surgery ]
    ASA I A normal healthy patient ASA II A patient with mild systemic disease ASA III A patient with severe systemic disease ASA IV A patient with severe systemic disease that is a constant threat to life ASA V A moribund patient who is not expected to survive without the operation ASA VI A declared brain-dead patient whose organs are being removed for donor purposes

  7. Optional opioid plasma concentrations - hydromorphone group [ Time Frame: up to 48 hours after surgery ]
    Blood collection at three time points using mass spectroscopy (This is optional for participants)

  8. Optional opioid plasma concentrations - fentanyl group [ Time Frame: up to 48 hours after surgery ]
    Blood collection at three time points using mass spectroscopy (This is optional for participants)

  9. Adverse events - hydromorphone group [ Time Frame: up to 48 hours after surgery ]
    Nausea/vomiting, witnessed apneic events, desaturation events, respiratory depression, re-intubation, decreased oxygen saturation

  10. Adverse events - fentanyl group [ Time Frame: up to 48 hours after surgery ]
    Nausea/vomiting, witnessed apneic events, desaturation events, respiratory depression, re-intubation, decreased oxygen saturation

  11. NIH PROMIS - hydromorphone group [ Time Frame: up to 48 hours after surgery ]
    Patient satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always

  12. NIH PROMIS - fentanyl group [ Time Frame: up to 48 hours after surgery ]
    Patient satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always

  13. NIH PROMIS - hydromorphone group [ Time Frame: up to 48 hours after surgery ]
    Patient caregiver satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always

  14. NIH PROMIS - fentanyl group [ Time Frame: up to 48 hours after surgery ]
    Patient caregiver satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always

  15. Child Hospital Survey (CAHPS) - hydromorphone group [ Time Frame: up to 48 hours after surgery ]
    Patient caregiver satisfaction. Scale of 1 - 4 with 1=never and 6=always

  16. Child Hospital Survey (CAHPS) - fentanyl group [ Time Frame: up to 48 hours after surgery ]
    Patient caregiver satisfaction. Scale of 1 - 4 with 1=never and 6=always



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Ages Eligible for Study:   2 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Children ages 2 to 15 years old
  2. Presenting for tonsillectomy or adenotonsillectomy surgery
  3. American Society of Anesthesiologists Physical Status (ASAPS) Classification 1, 2 or 3
  4. Provide Informed Consent / Assent (as appropriate)

Exclusion Criteria:

  1. Additional Concurrent surgeries, exclusive of myringotomy tubes
  2. Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04230681


Locations
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United States, Missouri
Washington University School of Medicine/Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Michael Montana, MD PhD Washington University School of Medicine
Publications:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04230681    
Other Study ID Numbers: 201912042
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Tonsillitis
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Fentanyl
Hydromorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics