Individualized Analgesia After Adenotonsillectomy

Analgesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02990910
• Other study ID #: IARA
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: February 2017

Study information

• Verified date: July 2020
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• Individualized opioid analgesia
(a)positive result 10µg/kg morphine; negative result 50µg/kg morphine.

Device:
• conventional opioid analgesia
(b) all received 25µg/kg morphine

Locations

Country	Name	City	State
China	Chilren's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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 from entering the PACU until the patient leaves,approx 1 hour.
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 from entering the PACU until the patient leaves,approx 1 hour.