Opioid Sparing Analgesia: Dexmedetomidine Versus Lidocaine for Intracranial Surgeries in Children

Study Overview
=================
Brief Summary
-----------------
Perioperative pain control is necessary in children as inadequate treatment may lead to progression of perception of pain and development of chronic pain in the future. Anesthetists tend to adopt approach to perioperative control of pain by non-opioid drugs that mediate pain modulation. Its use as opioid sparing analgesia in different surgeries leading to mixed results.

Detailed Description
-----------------
Site of study: This study will be carried out in neurosurgical operating rooms of Zagazig University Hospitals. b. Sample size: A pilot study was done to estimate percent of children need intraoperative fentanyl was (10%) for dexmedetomidine group, and ( 40%) for lidocaine group, at 0.05 α error and 0.2 β error . Sample size was calculated using Open Epi software, is 32 children in each group.

Official Title
-----------------
Opioid Sparing Analgesia: Intraoperative Infusion Dexmedetomidine Versus Lidocaine for Intracranial Surgeries in Children

Conditions
-----------------
Analgesia

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine injection
* Drug: Lidocaine Iv


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 6-18 years old. Sex: both sexes. Physical status: American Society Of Anesthesiologist 1& II. Body Mass Index >5 th and < the 85th percentile for age. Type of operations: elective intracranial surgeries under general anesthesia. Duration of operation < 3 hours. Written informed consent from the parent of child Exclusion Criteria: Altered mental state Unsuitability for extubation. Patients on beta blocker, alpha 2 agonist. Patients on pain killer or with known history of allergy to study drugs. Hepatic, renal, Cardiovascular and respiratory disease. The patient has the right to withdraw from the study at any time without any negative consequence on their medical or surgical treatment plan.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dexmedetomdine<br>IV bolus dose of 0.5ug/kg dexmedetomidine diluted in 10ml saline 1% over 15 minutes followed by continuous infusion of 0.5ug/kg/h | Drug: Dexmedetomidine injection<br>* receive IV bolus dose of 0.5 ug/kg dexmedetomidine diluted in 10ml saline 1% over 15 minutes followed by continuous infusion of 0.5 ug/kg/h<br>* Other names: precedex;|
| Active Comparator: lidocaine<br>IV bolus dose of 1mg/kg lidocaine 1% over 15 minutes followed by continuous infusion of 1.5mg/kg/h | Drug: Lidocaine Iv<br>* IV bolus dose of 1mg/kg lidocaine 1% over 15 minutes followed by continuous infusion of 1.5mg/kg/h<br>* Other names: xylocaine 1%;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative total fentanyl consumption. | Intraoperative fentanyl 0.5ug/ kg when the heart rate and mean arterial blood pressure of patients increased > 20% from basal measurement after exclusion of other causes. | from induction till end of surgery up to 3 hours intraoperative. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain intensity | In the Post Anesthesia Care Unite( PACU), the intensity of pain will be assessed using The Wong-Baker Faces Pain Rating Scale (WBFPS) . The scale shows a series of faces ranging from a happy face at 0, or no hurt, to a crying face at 10, which represents hurts like the worst pain imaginable. The child is instructed to choose the face that best describes their intensity of pain currently being experienced immediately on arrival to PACU, and at 5, 10, 15 mintues till the child will be discharge from PACU. The child will be ready for discharge from PACU when attained an Aldrete score ≥9 and free from pain, nausea and vomiting. Protocol for pain management, IV paracetamol 15mg/kg every 6h. maximum daily dose 60mg/kg not exceeding 2grams. Child with WBFPS score > 4 will be treated with nalbuphine 0.1mg/kg as rescue analgesic | immediately on arrival to PACU, and at 5, 10, 15 minutes till the child will be discharge from PACU postoperative. | 
| level of sedation | Assessment of level of sedation by 6-point Pediatric Sedation State Scale (PSSS) in the PACU :The six activity states are as follows: State 5: Movement impedes procedure and requires forceful immobilization State 4: Movement requires gentle immobilization for positioning State 3: Facial expression of pain or anxiety State 2: Quiet, not moving, no frown, no verbalization of complaint (ideal state) State 1: Deeply asleep with normal vital signs, but requires airway intervention or assistance (e.g., central or obstructive apnea) State 0: Deeply asleep with abnormal physiologic parameters that require acute intervention (e.g., O2 saturation <90%, hypotension, bradycardia). | up to one hour postoperative | 
| Time to first call for rescue analgesic (fentanyl) | Child with Wong-Baker Faces Pain Rating Scale (WBFPS) score > 4 will be treated with nalbuphine0.1 mg/kg as rescue analgesic as rescue analgesic. The Wong-Baker Faces Pain Rating Scale (WBFPS) . The scale shows a series of faces ranging from a happy face at 0, or no hurt, to a crying face at 10, which represents hurts like the worst pain imaginable. The child is instructed to choose the face that best describes their intensity of pain currently being experienced | up to one hour postoperative | 
| Total amount of nalbuphine consumption | Total amount of nalbuphine consumption in the first 12 hour postoperative | up to twelve hours postoperative | 
| The duration of Post Anesthesia Care Unite stay | The child will be ready for discharge from PACU to word when attained modified Aldrete score ≥9, fully conscious and no complaint of pain. | up to 2 hour postoperative | 
| side-effects | side- effects including hypotension MAP < 60, bradycardia HR < 60b/m. | up to 12 hour postoperative |