Analgesia
Conditions
Keywords
respiratory adverse events, adenotonsillectomy, opioid analgesia, children
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.
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.
Interventions
DRUGIndividualized opioid analgesia
(a）positive result 10μg/kg morphine; negative result 50μg/kg morphine.
DEVICEconventional opioid analgesia
(b) all received 25μg/kg morphine
Sponsors
Children's Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Patients Requiring at Least One Medical Intervention for Respiratory Events | 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
| Measure | Time frame | Description |
|---|---|---|
| The Median Survival Time for CHEOPS Score > 6. | 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. |
Countries
China
Participant flow
Recruitment details
children who scheduled for adenotonsillectomy under general anesthesia
Pre-assignment details
Patients with a history of allergy, pulmonary or cardiac diseases were excluded.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 140 |
| 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 | 140 |
| Total | 280 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 6 | 10 |
Baseline characteristics
| Characteristic | Individualized Opioid Analgesia | Total | Conventional Opioid Analgesia |
|---|---|---|---|
| Age, Continuous | 6 years | 6 years | 5 years |
| BMI | 18 kg / m^2 | 18 kg / m^2 | 18 kg / m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 140 Participants | 280 Participants | 140 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Chinese | 140 Participants | 280 Participants | 140 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 140 Participants | 280 Participants | 140 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 140 participants | 280 participants | 140 participants |
| Sex: Female, Male Female | 48 Participants | 100 Participants | 52 Participants |
| Sex: Female, Male Male | 86 Participants | 164 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 16 / 134 | 29 / 130 |
| other Total, other adverse events | 16 / 134 | 22 / 130 |
| serious Total, serious adverse events | 0 / 134 | 0 / 130 |
Outcome results
Primary
The Percentage of Patients Requiring at Least One Medical Intervention for Respiratory Events
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%.
Time frame: Time from entering the PACU until the patient leaves,approx 1 hour.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Individualized Opioid Analgesia | The Percentage of Patients Requiring at Least One Medical Intervention for Respiratory Events | 16 Participants |
| Conventional Opioid Analgesia | The Percentage of Patients Requiring at Least One Medical Intervention for Respiratory Events | 29 Participants |
Comparison: Chi square test was used to compare the count data,p \< 0.05 was considered statistically significant.p-value: <0.05Chi-squared
Secondary
The Median Survival Time for CHEOPS Score > 6.
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.
Time frame: Time from entering the PACU until the patient leaves,approx 1 hour.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Individualized Opioid Analgesia | The Median Survival Time for CHEOPS Score > 6. | 20 minute |
| Conventional Opioid Analgesia | The Median Survival Time for CHEOPS Score > 6. | 30 minute |