A Phase 4 interventional study of The dexamethasone plus ropivacaine and The ropivacaine in Pain, Postoperative and Children, sponsored by Beijing Tiantan Hospital. Completed at 2 sites in China. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2020-07-21.
Sponsored by Beijing Tiantan Hospital · Phase 4, Interventional, and Prevention
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 80 is close to the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 282 are open to participants now.
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Exclusion Criteria:
Patients in the dexamethasone plus ropivacaine group will receive a peri-incisional scalp infiltration with 0.025% dexamethasone and 0.2% ropivacaine and normal saline miscible liquids.
Drug: The dexamethasone plus ropivacaine
Patients in the ropivacaine group will receive a peri-incisional scalp infiltration with 0.2% ropivacaine and normal saline miscible liquids.
Drug: The 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.
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.
modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS)
Postoperative pain will be estimated by using the modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS). 0 indicates no pain, 10 indicates the most severe pain imaginable.
Time frame: At 24 hours after the operation
modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS)
Postoperative pain will be estimated by using the modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS). 0 indicates no pain, 10 indicates the most severe pain imaginable.
Time frame: At 2 hours, 4 hours, 8 hours, 48 hours, 72 hours, 1 week, 2 weeks after surgery
The time to the first rescue analgesic
Rescue analgesics will be administered if the patient exhibits signs of sympathetic stimulation in the form of undue tachycardia, a rise in mean arterial pressure (rise of \>20% from the baseline), and mCHEOPS score above 5 (range 1 to 10) or if the children are in obvious pain and distress at any time point during a subjective assessment by the intensivist or parents.
Time frame: Within 48 hours after the operation
Patient satisfactory scale (PSS)
0 for unsatisfactory, and 10 for very satisfied
Time frame: At 2 hours, 4 hours, 8 hours, 48 hours, 72 hours, 1 week, 2 weeks after surgery
length of stay (LOS)
LOS will be recorded as the number of nights spent in hospital after surgery.
Time frame: Approximately 2 weeks after the operation
The occurrence of postoperative nausea and vomiting (PONV)
PONV will be rated by participants as: 0, absent; 1, nausea not requiring treatment; 2, nausea requiring treatment; and 3, vomiting.
Time frame: At 2 hours, 4 hours, 8 hours, 24 hours after surgery
Ramsay Sedation Scale (RSS)
1: Anxious, agitated, restless; Ramsey 2: Cooperative, oriented, tranquil; Ramsey 3: Responsive to commands only If Asleep; Ramsey 4: Brisk response to light glabellar tap or loud auditory stimulus; Ramsey 5: Sluggish response to light glabellar tap or loud auditory stimulus; Ramsey 6: No response to light glabellar tap or loud auditory stimulus.
Time frame: At 2 hours, 4 hours, 8 hours, 24 hours after surgery
The occurrence of respiratory depression
Respiratory depression is defined as persistent (more than 1 minutes) oxygen desaturation 90 percent or respiratory rate less than 8 breaths per minute, or oxygen desaturation less than 94 percent along with respiratory rate less than 10 breaths per minute requiring supplemental oxygen to maintain oxygen saturation more than 94 percent in the absence of clinically obvious upper airway obstruction.
Time frame: Within 48 hours after the operation
Heart rate
Time frame: During the operation and at 2 hours, 4 hours, 8 hours, 24 hours after surgery
Mean arterial pressure
Time frame: During the operation and at 2 hours, 4 hours, 8 hours, 24 hours after surgery
The total consumption of opioids during the operation
Time frame: During procedure
The total consumption of anaesthetic during the operation
Time frame: During procedure
Wound Healing Score
Skin Healing 1: fully healed; 2: ≤3 cm in total not healed; 3: \>3 cm not healed; 4: areas of necrosis ≤3 cm; 5: areas of necrosis \>3 cm Infection 1: none; 2: ≤0.5-cm margin of redness; 3: more redness or superficial pus; 4: deep infection; not applicable Hair Regrowth 1: even regrowth along wound; 2: ≤3 cm not regrowing; 3: \>3-6 cm not regrowing; 4: \>6 cm not regrowing; not applicable
Time frame: At 1 month after surgery
Incisional related adverse events
Incisional related adverse events Including delayed incisional healing, incisional infection, intracranial infection, scar healing.
Time frame: Approximately 2 weeks after the operation
The occurrence of the Adverse events (AEs) and serious adverse events (SAEs)
An AE was defined as any untoward medical occurrence. An SAE included death, immediately life-threatening conditions, coma, in-patient hospitalisation or prolongation of existing hospitalisation.
Time frame: Within 2 weeks after the operation
Plan to share: Yes
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Beijing Tiantan Hospital