A Phase 4 interventional study of Individualized oral morphine and Conventional oral morphine in Adenotonsillectomy and Analgesia, sponsored by Children's Hospital of Fudan University. Completed at 1 site in China. Open to participants aged 3 Years to 10 Years. Per ClinicalTrials.gov, last updated 2024-02-28.
Sponsored by Children's Hospital of Fudan University · Phase 4, Interventional, and Treatment
The objective of this randomized clinical trial is to assess the safety and effectiveness of post-adenotonsillectomy analgesia with individualized opioid analgesia regime in children.
Patients will be randomly assigned to individualized opioid analgesia regimen group or conventional opioid analgesia regimen group.
Intravenous 1μg/kg fentanyl is administered as a test in patients with spontaneous breath after sevoflurane induction. A positive result is defined as a decrease of more than 50% in spontaneous respiratory rate (rate after fentanyl test versus rate before fentanyl test). Otherwise it is defined as a negative result.
All the patients are given regular paracetamol and ibuprofen after surgery. The addition of rescue oral morphine is given as needed. The dose of oral morphine is determined according to the results of fentanyl test in the individualized group, while the patients in the conventional group are given the routine dose. The Faces Scale is used to assess analgesic effectiveness by parents from postoperative day 1 to day 10. If the Faces Scale score > 6, the child receive rescue oral morphine analgesia.
At the preoperative appointment, parents are provided with a pulse oximeter including oxygen saturation sensors to take home. The oxygen saturation per night during sleep will be monitored using the pulse oximeter by parents from postoperative Day 1 to Day 10. The research team will instruct parents on how to properly apply the oximeter to the child and repeat these measurements. The primary outcome measure is desaturation events during sleep per night.
1,190 studies on the registry are indexed under Agnosia; 507 are open to participants now.
This study's enrollment of 542 is above the median of 77 across 1,023 interventional studies indexed under Agnosia.
Browse Agnosia studies →Children's Hospital of Fudan University is the lead sponsor of 262 studies on the registry; 92 are open to participants now.
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Exclusion Criteria:
The dose of oral morphine for patients in the individualized group is determined according to the results of fentanyl test.
Drug: Individualized oral morphine
Patients in the conventional group are given routine dose of oral morphine.
Drug: Conventional oral morphine
Analgesic effectiveness is assessed using the Faces Scale by the parents every four hours from postoperative Day 1 to Day 10 (eg: 8:00, 12:00, 16:00, and 20:00, each day). If the Faces Scale score \> 6, the child receive rescue oral morphine analgesia. Patients with positive results of fentanyl test receive oral morphine 100μg/kg per dose, while patients with negative results receive oral morphine 500μg/kg per dose.
Also known as: Individualized group
Analgesic effectiveness is assessed using the Faces Scale by the parents every four hours from postoperative Day 1 to Day 10 (eg: 8:00, 12:00, 16:00, and 20:00, each day). If the Faces Scale score \> 6, the child receive rescue oral morphine analgesia. Patients receive oral morphine 200μg/kg per dose.
Also known as: Conventional group
Desaturation events
The oxygen saturation per night during sleep will be monitored using a pulse oximeter by the parents from postoperative Day 1 to Day 10. The research team will instruct parents on how to properly apply the oximeter to the child and repeat these measurements. The primary outcome measure is desaturation events during sleep per night.
Time frame: from postoperative day 1 to day 10, each night
Scores of Pain Scale (the Faces Scale)
Analgesic effectiveness was assessed using the Faces Scale by the parents every four hours from postoperative Day 1 to Day 10. Parents are trained by the research staff on how to complete pain scale.
Time frame: every four hours from postoperative Day 1 to Day 10 (eg: 8:00, 12:00, 16:00, and 20:00, each day)
Scores of Pain Scale (the Objective Pain Scale)
Analgesic effectiveness was assessed using the Objective Pain Scale by the parents every four hours from postoperative Day 1 to Day 10. Parents are trained by the research staff on how to complete pain scale.
Time frame: every four hours from postoperative Day 1 to Day 10 (eg: 8:00, 12:00, 16:00, and 20:00, each day)
Tonsillar bleeding events
This include any signs of significant oral or nasal bleeding. It is recorded by the parents as occurring or not; if so, the number of occurrences and the time of each occurrence should be recorded.
Time frame: from postoperative day 1 to day 10
Adverse drug reactions
It is recorded by the parents as occurring or not; if so, the time of occurrence and the type of adverse reaction need to be recorded.
Time frame: from postoperative day 1 to day 10
Plan to share: No
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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Children's Hospital of Fudan University