Status:
COMPLETED
Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine for Post-Craniotomy Pain in Children
Lead Sponsor:
Beijing Tiantan Hospital
Collaborating Sponsors:
Beijing Children's Hospital
Conditions:
Pain, Postoperative
Children
Eligibility:
All Genders
2-12 years
Phase:
PHASE4
Brief Summary
At present, pediatric postoperative analgesia has not been fully understood and controlled, particularly craniotomy surgery. On the one hand, professional evaluation of postoperative pain for young ch...
Eligibility Criteria
Inclusion
- An elective craniotomy under general anesthesia;
- American Society of Anesthesiologists (ASA) physical status of I or II;
- Participates with an anticipated fully recovery within 2 hours postoperatively;
- Informed consent by parent(s) and/or legal guardian.
Exclusion
- History of allergies to any of the study drugs;
- Drugs with confirmed or suspected sedative or analgesic effects; receiving any painkiller within 24 h before surgery; children who received steroids;
- Psychiatric disorders;
- Uncontrolled epilepsy;
- Chronic headache;
- Peri-incisional infection;
- Body mass index exceeded the 99th percentile for age;
- Children who must use a patient-controlled analgesia (PCA) device;
- Children who cannot understand an instruction of pain scales before surgery.
Key Trial Info
Start Date :
September 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 5 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04051723
Start Date
September 2 2019
End Date
July 5 2020
Last Update
July 21 2020
Active Locations (2)
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1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100050
2
Beijing children's hospital affiliated to capital medical university
Beijing, Beijing Municipality, China