N/A
N=280
Individualized Analgesia After Adenotonsillectomy
Analgesia
Bottom Line
View on ClinicalTrials.gov: NCT02990910 ↗Enrolled (actual)
280
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: The Percentage of Patients Requiring at Least One Medical Intervention for Respiratory Events — 16; 29 Participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Individualized opioid analgesia (Drug); conventional opioid analgesia (Device)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Fudan University
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Patients Requiring at Least One Medical Intervention for Respiratory Events |
16; 29 | <0.05 sig |
| SECONDARY The Median Survival Time for CHEOPS Score > 6. |
20; 30 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02990910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.