Individualized Analgesia After Adenotonsillectomy

• Sponsor: Children's Hospital of Fudan University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02990910
• Collaborator: (none)
• Enrollment: 280
• Location: 1
• Arms: 2
• Actual Duration (Months): 3
• Patients Per Site Per Month: 92.6

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• 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: Nov 1, 2016
• Actual Primary Completion Date: Feb 1, 2017
• Actual Study Completion Date: Feb 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: 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 Names: IP
Other: 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 Names: CP

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 10 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chilren's Hospital of Fudan University	Shanghai	Shanghai	China	201102

Sponsors and Collaborators

• Children's Hospital of Fudan University

Investigators

• Principal Investigator: xuan wang, Children's Hospital of Fudan University

Study Documents (Full-Text)

• Statistical Analysis Plan - Feb 15, 2017
• Informed Consent Form - Feb 15, 2017
• Study Protocol - Feb 15, 2017

More Information

Publications

None provided.

• Responsible Party: Xuan Wang, Doctor, Children's Hospital of Fudan University
• ClinicalTrials.gov Identifier: NCT02990910
• Other Study ID Numbers: IARA
• First Posted: Dec 13, 2016
• Last Update Posted: Jul 21, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Xuan Wang, Doctor, Children's Hospital of Fudan University: respiratory adverse events; adenotonsillectomy; opioid analgesia; children
• Additional relevant MeSH terms: Agnosia; Analgesics, Opioid

Study Results

Participant Flow

Recruitment Details	children who scheduled for adenotonsillectomy under general anesthesia
Pre-assignment Detail	Patients with a history of allergy, pulmonary or cardiac diseases were excluded.

Arm/Group Title	Individualized Opioid Analgesia	Conventional Opioid Analgesia
Arm/Group Description	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.	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
Period Title: Overall Study
STARTED	140	140
COMPLETED	134	130
NOT COMPLETED	6	10

Baseline Characteristics

Arm/Group Title	Individualized Opioid Analgesia	Conventional Opioid Analgesia	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	140	140	280
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	6	5	6
Sex: Female, Male (Count of Participants)
Female	48 34.3%	52 37.1%	100 35.7%
Male	86 61.4%	78 55.7%	164 58.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	140 100%	140 100%	280 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	140 100%	140 100%	280 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Chinese	140 100%	140 100%	280 100%
Region of Enrollment (participants) [Number]
China	140 100%	140 100%	280 100%
BMI (kg / m^2) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [kg / m^2]	18	18	18

Outcome Measures

1. Primary Outcome

Title	The Percentage of Patients Requiring at Least One Medical Intervention for Respiratory Events
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Individualized Opioid Analgesia	Conventional Opioid Analgesia
Arm/Group Description	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.	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
Measure Participants	134	130
Count of Participants [Participants]	16 11.4%	29 20.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Individualized Opioid Analgesia, Conventional Opioid Analgesia
	Comments	Chi square test was used to compare the count data,p < 0.05 was considered statistically significant.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Chi-squared
	Comments

2. Secondary Outcome

Title	The Median Survival Time for CHEOPS Score > 6.
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Individualized Opioid Analgesia	Conventional Opioid Analgesia
Arm/Group Description	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.	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
Measure Participants	134	130
Median (95% Confidence Interval) [minute]	20	30

Adverse Events

Time Frame	Time from entering the PACU until the patient leaves,approx 1 hour.
Adverse Event Reporting Description	Respiratory adverse events were defined as an intervention requiring a nurse to maintain the SPO2 ≥95%.
Arm/Group Title	Individualized Opioid Analgesia		Conventional Opioid Analgesia
Arm/Group Description	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.		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
All Cause Mortality
	Individualized Opioid Analgesia		Conventional Opioid Analgesia
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/134 (11.9%)		29/130 (22.3%)
Serious Adverse Events
	Individualized Opioid Analgesia		Conventional Opioid Analgesia
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/134 (0%)		0/130 (0%)
Other (Not Including Serious) Adverse Events
	Individualized Opioid Analgesia		Conventional Opioid Analgesia
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/134 (11.9%)		22/130 (16.9%)
Surgical and medical procedures
Post Operative Nausea And Vomitting	16/134 (11.9%)	16	22/130 (16.9%)	22

Limitations/Caveats

The absence of PSG assessment before surgery in patients recruited in this study is a limitation.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.