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
|Condition or disease||Intervention/treatment||Phase|
|Analgesia||Drug: Individualized opioid analgesia Device: conventional opioid analgesia||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||280 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- 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%.
- 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.
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
|Chilren's Hospital of Fudan University|
|Shanghai, Shanghai, China, 201102|
|Principal Investigator:||xuan wang||Children's Hospital of Fudan University|