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NCT Number: NCT04051723

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

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.

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Key information

Conditions

Pain, Postoperative Children Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Tiantan Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The dexamethasone plus ropivacaine

Drug

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 ropivacaine

Drug

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.

Primary outcomes

  1. modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS)

    Time frame: At 24 hours after the operation

    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.

Secondary outcomes

  1. modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS)

    Time frame: At 2 hours, 4 hours, 8 hours, 48 hours, 72 hours, 1 week, 2 weeks after surgery

    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.

  2. The time to the first rescue analgesic

    Time frame: Within 48 hours after the operation

    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.

  3. Patient satisfactory scale (PSS)

    Time frame: At 2 hours, 4 hours, 8 hours, 48 hours, 72 hours, 1 week, 2 weeks after surgery

    0 for unsatisfactory, and 10 for very satisfied

  4. length of stay (LOS)

    Time frame: Approximately 2 weeks after the operation

    LOS will be recorded as the number of nights spent in hospital after surgery.

  5. The occurrence of postoperative nausea and vomiting (PONV)

    Time frame: At 2 hours, 4 hours, 8 hours, 24 hours after surgery

    PONV will be rated by participants as: 0, absent; 1, nausea not requiring treatment; 2, nausea requiring treatment; and 3, vomiting.

  6. Ramsay Sedation Scale (RSS)

    Time frame: At 2 hours, 4 hours, 8 hours, 24 hours after surgery

    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.

  7. The occurrence of respiratory depression

    Time frame: Within 48 hours after the operation

    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.

  8. Heart rate

    Time frame: During the operation and at 2 hours, 4 hours, 8 hours, 24 hours after surgery

  9. Mean arterial pressure

    Time frame: During the operation and at 2 hours, 4 hours, 8 hours, 24 hours after surgery

  10. The total consumption of opioids during the operation

    Time frame: During procedure

  11. The total consumption of anaesthetic during the operation

    Time frame: During procedure

  12. Wound Healing Score

    Time frame: At 1 month after surgery

    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

  13. Incisional related adverse events

    Time frame: Approximately 2 weeks after the operation

    Incisional related adverse events Including delayed incisional healing, incisional infection, intracranial infection, scar healing.

  14. The occurrence of the Adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Within 2 weeks after the operation

    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.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Beijing Children's Hospital

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 9, 2019
Registry last updated
Jul 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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