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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04535089
• Other study ID #: 6318
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 1, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: December 2021
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• Dexmedetomidine injection
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
• Lidocaine Iv
IV bolus dose of 1mg/kg lidocaine 1% over 15 minutes followed by continuous infusion of 1.5mg/kg/h

Locations

Country	Name	City	State
Egypt	Zagazig University, Faculty of medicine	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	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
Secondary	Total amount of nalbuphine consumption	Total amount of nalbuphine consumption in the first 12 hour postoperative	up to twelve hours postoperative
Secondary	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
Secondary	side-effects	side- effects including hypotension MAP < 60, bradycardia HR < 60b/m.	up to 12 hour postoperative