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

Primary Purpose

Analgesia

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine injection
Lidocaine Iv
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Zagazig University, Faculty of medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

dexmedetomdine

lidocaine

Arm Description

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

IV bolus dose of 1mg/kg lidocaine 1% over 15 minutes followed by continuous infusion of 1.5mg/kg/h

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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).
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
Total amount of nalbuphine consumption
Total amount of nalbuphine consumption in the first 12 hour 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.
side-effects
side- effects including hypotension MAP < 60, bradycardia HR < 60b/m.

Full Information

First Posted
August 22, 2020
Last Updated
December 1, 2021
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT04535089
Brief Title
Opioid Sparing Analgesia: Dexmedetomidine Versus Lidocaine for Intracranial Surgeries in Children
Official Title
Opioid Sparing Analgesia: Intraoperative Infusion Dexmedetomidine Versus Lidocaine for Intracranial Surgeries in Children
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dexmedetomdine
Arm Type
Active Comparator
Arm Description
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
Arm Title
lidocaine
Arm Type
Active Comparator
Arm Description
IV bolus dose of 1mg/kg lidocaine 1% over 15 minutes followed by continuous infusion of 1.5mg/kg/h
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine injection
Other Intervention Name(s)
precedex
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Lidocaine Iv
Other Intervention Name(s)
xylocaine 1%
Intervention Description
IV bolus dose of 1mg/kg lidocaine 1% over 15 minutes followed by continuous infusion of 1.5mg/kg/h
Primary Outcome Measure Information:
Title
Intraoperative total fentanyl consumption.
Description
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.
Time Frame
from induction till end of surgery up to 3 hours intraoperative.
Secondary Outcome Measure Information:
Title
pain intensity
Description
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
Time Frame
immediately on arrival to PACU, and at 5, 10, 15 minutes till the child will be discharge from PACU postoperative.
Title
level of sedation
Description
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).
Time Frame
up to one hour postoperative
Title
Time to first call for rescue analgesic (fentanyl)
Description
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
Time Frame
up to one hour postoperative
Title
Total amount of nalbuphine consumption
Description
Total amount of nalbuphine consumption in the first 12 hour postoperative
Time Frame
up to twelve hours postoperative
Title
The duration of Post Anesthesia Care Unite stay
Description
The child will be ready for discharge from PACU to word when attained modified Aldrete score ≥9, fully conscious and no complaint of pain.
Time Frame
up to 2 hour postoperative
Title
side-effects
Description
side- effects including hypotension MAP < 60, bradycardia HR < 60b/m.
Time Frame
up to 12 hour postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alshaimaa Kamel, M.D
Organizational Affiliation
Zagazig University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zagazig University, Faculty of medicine
City
Zagazig
Country
Egypt

12. IPD Sharing Statement

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

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