Trial Outcomes & Findings for Individualized Analgesia After Adenotonsillectomy (NCT NCT02990910)

Last Updated: 2020-07-21

Results Overview

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%.

Recruitment status

COMPLETED

Study phase

Target enrollment

280 participants

Primary outcome timeframe

Time from entering the PACU until the patient leaves,approx 1 hour.

Results posted on

2020-07-21

Participant Flow

children who scheduled for adenotonsillectomy under general anesthesia

Patients with a history of allergy, pulmonary or cardiac diseases were excluded.

Participant milestones

Participant milestones
Measure	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. personalized opioid analgesia: (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine.	Conventional Opioid Analgesia Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS\<=6 and Aldrete score\>9. conventional opioid analgesia: (b) all received 25μg/kg morphine
Overall Study STARTED	140	140
Overall Study COMPLETED	134	130
Overall Study NOT COMPLETED	6	10

Reasons for withdrawal

Reasons for withdrawal
Measure	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. personalized opioid analgesia: (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine.	Conventional Opioid Analgesia Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS\<=6 and Aldrete score\>9. conventional opioid analgesia: (b) all received 25μg/kg morphine
Overall Study Lack of Efficacy	6	10

Baseline Characteristics

The children with cough after intravenous fentanyl, the study was excluded

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Time from entering the PACU until the patient leaves,approx 1 hour.

Outcome measures

Outcome measures
Measure	Individualized Opioid Analgesia n=134 Participants One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS\<=6 and Aldrete score\>9. personalized opioid analgesia: (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine.	Conventional Opioid Analgesia n=130 Participants Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS\<=6 and Aldrete score\>9. conventional opioid analgesia: (b) all received 25μg/kg morphine
The Percentage of Patients Requiring at Least One Medical Intervention for Respiratory Events	16 Participants	29 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Individualized Opioid Analgesia n=134 Participants One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS\<=6 and Aldrete score\>9. personalized opioid analgesia: (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine.	Conventional Opioid Analgesia n=130 Participants Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS\<=6 and Aldrete score\>9. conventional opioid analgesia: (b) all received 25μg/kg morphine
The Median Survival Time for CHEOPS Score > 6.	20 minute Interval 17.0 to 23.0	30 minute Interval 28.0 to 32.0

Adverse Events

Individualized Opioid Analgesia

Serious events: 0 serious events

Other events: 16 other events

Deaths: 16 deaths

Conventional Opioid Analgesia

Serious events: 0 serious events

Other events: 22 other events

Deaths: 29 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Individualized Opioid Analgesia n=134 participants at risk One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS\<=6 and Aldrete score\>9. personalized opioid analgesia: (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine.	Conventional Opioid Analgesia n=130 participants at risk Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS\<=6 and Aldrete score\>9. conventional opioid analgesia: (b) all received 25μg/kg morphine
Surgical and medical procedures Post Operative Nausea And Vomitting	11.9% 16/134 • Number of events 16 • Time from entering the PACU until the patient leaves,approx 1 hour. Respiratory adverse events were defined as an intervention requiring a nurse to maintain the SPO2 ≥95%.	16.9% 22/130 • Number of events 22 • Time from entering the PACU until the patient leaves,approx 1 hour. Respiratory adverse events were defined as an intervention requiring a nurse to maintain the SPO2 ≥95%.

Additional Information

Dr.Wang Xuan

the Children's Hospital of Fudan University

Phone: 18017591058

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Individualized Opioid Analgesia n=140 Participants One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS\<=6 and Aldrete score\>9. personalized opioid analgesia: (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine.	Conventional Opioid Analgesia n=140 Participants Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS\<=6 and Aldrete score\>9. conventional opioid analgesia: (b) all received 25μg/kg morphine	Total n=280 Participants Total of all reporting groups
Age, Continuous	6 years n=140 Participants	5 years n=140 Participants	6 years n=280 Participants
Sex: Female, Male Female	48 Participants n=134 Participants • The children with cough after intravenous fentanyl, the study was excluded	52 Participants n=130 Participants • The children with cough after intravenous fentanyl, the study was excluded	100 Participants n=264 Participants • The children with cough after intravenous fentanyl, the study was excluded
Sex: Female, Male Male	86 Participants n=134 Participants • The children with cough after intravenous fentanyl, the study was excluded	78 Participants n=130 Participants • The children with cough after intravenous fentanyl, the study was excluded	164 Participants n=264 Participants • The children with cough after intravenous fentanyl, the study was excluded
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=140 Participants	0 Participants n=140 Participants	0 Participants n=280 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	140 Participants n=140 Participants	140 Participants n=140 Participants	280 Participants n=280 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=140 Participants	0 Participants n=140 Participants	0 Participants n=280 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=140 Participants	0 Participants n=140 Participants	0 Participants n=280 Participants
Race (NIH/OMB) Asian	140 Participants n=140 Participants	140 Participants n=140 Participants	280 Participants n=280 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=140 Participants	0 Participants n=140 Participants	0 Participants n=280 Participants
Race (NIH/OMB) Black or African American	0 Participants n=140 Participants	0 Participants n=140 Participants	0 Participants n=280 Participants
Race (NIH/OMB) White	0 Participants n=140 Participants	0 Participants n=140 Participants	0 Participants n=280 Participants
Race (NIH/OMB) More than one race	0 Participants n=140 Participants	0 Participants n=140 Participants	0 Participants n=280 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=140 Participants	0 Participants n=140 Participants	0 Participants n=280 Participants
Race/Ethnicity, Customized Chinese	140 Participants n=140 Participants	140 Participants n=140 Participants	280 Participants n=280 Participants
Region of Enrollment China	140 participants n=140 Participants	140 participants n=140 Participants	280 participants n=280 Participants
BMI	18 kg / m^2 n=140 Participants	18 kg / m^2 n=140 Participants	18 kg / m^2 n=280 Participants