Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery

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Primary Purpose

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Hydromorphone

Fentanyl

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

2 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Additional Concurrent surgeries, exclusive of myringotomy tubes, minor oral/nasal procedures (e.g. frenulectomy), and endoscopic procedures
Revision tonsillectomy or revision adenotonsillectomy surgery
Known pregnancy
Any condition which would make the participant, in the opinion of the investigator or the attending anesthesiologist caring for the patient, unsuitable for the study.

Sites / Locations

Washington University School of Medicine/Barnes-Jewish Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Fentanyl

Hydromorphone

Arm Description

Outcomes

Primary Outcome Measures

Amount of rescue opioid medications administered - hydromorphone group

Postoperative opioid medication expressed in morphine equivalents

Amount of rescue opioid medications administered - fentanyl group

Postoperative opioid medication expressed in morphine equivalents

Evaluation of participant's pain - hydromorphone group

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

Evaluation of participant's pain - fentanyl group

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

Preoperative Amsterdam Preoperative Anxiety Scale - hydromorphone group

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.

Preoperative Amsterdam Preoperative Anxiety Scale - fentanyl group

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.

Yale Preoperative Anxiety Scale - hydromorphone group

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.

Yale Preoperative Anxiety Scale - fentanyl group

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.

ASA physical status classification score from preoperative assessment - hydromorphone group

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

ASA physical status classification score from preoperative assessment - fentanyl group

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

Optional opioid plasma concentrations - hydromorphone group

Blood collection at three time points using mass spectroscopy (This is optional for participants)

Optional opioid plasma concentrations - fentanyl group

Blood collection at three time points using mass spectroscopy (This is optional for participants)

Adverse events - hydromorphone group

Nausea/vomiting, witnessed apneic events, desaturation events, respiratory depression, re-intubation, decreased oxygen saturation

Adverse events - fentanyl group

Nausea/vomiting, witnessed apneic events, desaturation events, respiratory depression, re-intubation, decreased oxygen saturation

NIH PROMIS - hydromorphone group

Patient satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always

NIH PROMIS - fentanyl group

Patient satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always

NIH PROMIS - hydromorphone group

Patient caregiver satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always

NIH PROMIS - fentanyl group

Patient caregiver satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always

Child Hospital Survey (CAHPS) - hydromorphone group

Patient caregiver satisfaction. Scale of 1 - 4 with 1=never and 6=always

Child Hospital Survey (CAHPS) - fentanyl group

Patient caregiver satisfaction. Scale of 1 - 4 with 1=never and 6=always

Full Information

NCT ID

NCT04230681

First Posted

December 27, 2019

Last Updated

March 1, 2023

Sponsor

Washington University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT04230681

Brief Title

Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery

Official Title

A Randomized Controlled Trial to Compare Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

February 26, 2020 (Actual)

Primary Completion Date

April 1, 2022 (Actual)

Study Completion Date

April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

4. Oversight

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

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea, Tonsillitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

189 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fentanyl

Arm Type

Active Comparator

Arm Title

Hydromorphone

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Hydromorphone

Intervention Description

Patients will be randomized to one of two opioids for the treatment of post-operative pain.

Intervention Type

Drug

Intervention Name(s)

Fentanyl

Intervention Description

Fentanyl

Primary Outcome Measure Information:

Title

Amount of rescue opioid medications administered - hydromorphone group

Description

Postoperative opioid medication expressed in morphine equivalents

Time Frame

up to 48 hours post surgery

Title

Amount of rescue opioid medications administered - fentanyl group

Description

Postoperative opioid medication expressed in morphine equivalents

Time Frame

up to 48 hours post surgery

Title

Evaluation of participant's pain - hydromorphone group

Description

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

Time Frame

up to 48 hours post surgery

Title

Evaluation of participant's pain - fentanyl group

Description

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

Time Frame

up to 48 hours post surgery

Secondary Outcome Measure Information:

Title

Preoperative Amsterdam Preoperative Anxiety Scale - hydromorphone group

Description

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.

Time Frame