Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine for Post-Craniotomy Pain in Children

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 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 dexamethasone 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 dexamethasone to local infiltration for patients receiving craniotomy. Thus, investigators suppose that pre-emptive scalp infiltration with steroid (Dexamethasone) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in children.

Conditions

• Pain, Postoperative
• Children

Interventions

DRUG

The dexamethasone plus ropivacaine

The local infiltration solution containing 0.25mg Dexamethasone and 2mg ropivacaine per milliliter. The total volume is 20 ml. The assigned solution will be injected subcutaneously by surgeons along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigators.

DRUG

The ropivacaine

The local infiltration solution containing 2mg ropivacaine per milliliter. The total volume is 20 ml. The assigned solution will be injected subcutaneously by surgeons along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigators.

Sponsors & Collaborators

• Beijing Children's Hospital

  collaborator OTHER

• Beijing Tiantan Hospital

  lead OTHER

Principal Investigators

• Fang Luo, M.D. · Beijing Tiantan Hospital

• Ming Ge, M.D. · Beijing Children' Hospital, Capital Medical University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-09-02

Primary Completion

2020-06-05

Completion

2020-07-05

Countries

• China

Study Locations