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Pre-emptive Infiltration of the Scalp with Diprospan Plus Ropivacaine for Pain After Craniotomy in Children

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Capital Medical University

Status

Completed

Conditions

Postoperative Children
Pain

Treatments

Drug: The diprospan plus ropivacaine group
Drug: The ropivacaine group

Study type

Interventional

Funder types

Other

Identifiers

NCT06321354
KY 2018-066-02-3

Details and patient eligibility

About

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 children is difficult; on the other hand, the particularity of craniotomy adds (such as consciousness obstacle, sleepiness, et al) disturbance to the pain assessment in children. Although opioids administration is regarded as the first-line analgesic for post-craniotomy pain management, it may be associated with delayed awakening, respiratory depression, hypercarbia and it may interfere with the neurologic examination. For the avoidance of side-effects of systemic opioids, local anesthetics administered around the incision have been performed clinically. However, some studies revealed that the analgesic effect of local anesthetics was unsatisfactory due to its short pain relief duration, steroid as adjuvant can enhance postoperative analgesia and prolong postoperative analgesia time. As is reported that postoperative pain of craniotomy is mainly caused by skin incision and reflection of muscles, preventing the liberation of inflammatory mediators around the incision seems to be more effective than simply blocking nerve conduction. Researchers have clarified that the addition of diprospan to local infiltration of analgesia could provide significant analgesic effects and significantly prolong the duration of analgesic effects without obvious complications for various types of surgeries. To date, no studies have evaluated the addition of diprospan to local infiltration for patients receiving craniotomy.

Thus, investigators suppose that pre-emptive scalp infiltration with steroid (Diprospan) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in children.

Enrollment

108 patients

Sex

All

Ages

2 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • 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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Parallel Assignment

Masking

Double Blind

108 participants in 2 patient groups

The diprospan plus ropivacaine group
Experimental group
Description:
Patients in the diprospan plus ropivacaine group will receive a peri-incisional scalp infiltration with 15ml diprospan and 15mg of 1% ropivacaine and normal saline miscible liquids.
Treatment:
Drug: The diprospan plus ropivacaine group
The ropivacaine group
Active Comparator group
Description:
Patients in the ropivacaine group will receive a peri-incisional scalp infiltration with 15mg of 1%
Treatment:
Drug: The ropivacaine group

Trial contacts and locations

2

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Central trial contact

Luo Fang, M.D

Data sourced from clinicaltrials.gov

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