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Individualized Analgesia After Adenotonsillectomy

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: NCT02990910
Recruitment Status : Completed
First Posted : December 13, 2016
Results First Posted : August 9, 2017
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
Xuan Wang, Children's Hospital of Fudan University

Brief Summary:
A high incidence of respiratory morbidity after adenotonsillectomy is reported in children with obstructive sleep apnea syndrome (OSAS). So we designed a prospective, double-blind, randomized controlled study to determine the effects of individualized opioid analgesia compared with conventional opioid analgesia on respiratory morbidity after adenotonsillectomy in Children with OSAS.

Condition or disease Intervention/treatment Phase
Analgesia Drug: Individualized opioid analgesia Device: conventional opioid analgesia Not Applicable

Detailed Description:
All children were randomized 2 groups based on a computer-generated random number. The main interventions were occurred in post anesthetic care unit (PACU). In the operating room, all patients received a standardized anesthetic regimen by one anesthetist. Sevoflurane was used for maintenance without any opioids. Before the end of the procedure, spontaneous respiratory was recovered. All the patients were given 1 mcg/kg fentanyl intravenous injection after the end of the procedure. The positive result was defined as spontaneous respiratory rate decreased more than 50%, the others were defined as negative result. The result of fentanyl test submitted to assistant, and prepared the rescue analgesic drugs according to this result. One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine. Another group: all received 25μg/kg morphine .The trachea was extubated when patients were awake, and then transported to the PACU. Patients with a Children's Hospital of Eastern Ontario Pain Scale score>6 received rescue analgesic drugs and observe respiratory morbidity in each group.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of an Individualized Analgesia Protocol on the Requirements of Medical Interventions After Adenotonsillectomy in Children Based on the Result of a Fentanyl Test: a Randomized Controlled Trial
Actual Study Start Date : November 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Individualized opioid analgesia
One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.
Drug: Individualized opioid analgesia
(a)positive result 10μg/kg morphine; negative result 50μg/kg morphine.
Other Name: IP

conventional opioid analgesia
Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.
Device: conventional opioid analgesia
(b) all received 25μg/kg morphine
Other Name: CP




Primary Outcome Measures :
  1. The Percentage of Patients Requiring at Least One Medical Intervention for Respiratory Events [ Time Frame: Time from entering the PACU until the patient leaves,approx 1 hour. ]
    The medical interventions included instrumentation of the airway, bag/mask ventilation, and/or drug administration (succinylcholine, albuterol, or naloxone), which were classified as major medical interventions. The medical interventions also included repositioning of the child's airway, chin lift/jaw thrust maneuvers, and/or escalating to an oxygen mask, which were classified as minor medical interventions. Since oxygen by nasal cannula was delivered to all children recovering from anesthesia, escalating to an oxygen mask implied the patient need but higher concentration of oxygen to maintain SpO2 ≥ 95%.


Secondary Outcome Measures :
  1. The Median Survival Time for CHEOPS Score > 6. [ Time Frame: Time from entering the PACU until the patient leaves,approx 1 hour. ]
    Pain was assessed and recorded through the East Ontario children's hospital pain score (CHEOPS).When the CHEOPS>6,We thought it is painful. Comparing the median survival time (the time corresponding to pain percentage of 50% in two groups) for CHEOPS>6 in two groups.



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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children with obstructive sleep apnea syndrome undergoing elective T&A, ASA physical status I-II

Exclusion Criteria:

  • developmental delay cardiac and craniofacial abnormalities ASA classification III or more body mass index more than the 95th percentile for age

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): NCT02990910


Locations
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China, Shanghai
Chilren's Hospital of Fudan University
Shanghai, Shanghai, China, 201102
Sponsors and Collaborators
Children's Hospital of Fudan University
Investigators
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Principal Investigator: xuan wang Children's Hospital of Fudan University
  Study Documents (Full-Text)

Documents provided by Xuan Wang, Children's Hospital of Fudan University:
Statistical Analysis Plan  [PDF] February 15, 2017
Informed Consent Form  [PDF] February 15, 2017
Study Protocol  [PDF] February 15, 2017

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Responsible Party: Xuan Wang, Doctor, Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT02990910    
Other Study ID Numbers: IARA
First Posted: December 13, 2016    Key Record Dates
Results First Posted: August 9, 2017
Last Update Posted: July 21, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xuan Wang, Children's Hospital of Fudan University:
respiratory adverse events
adenotonsillectomy
opioid analgesia
children
Additional relevant MeSH terms:
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Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents