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

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

Sponsors

Lead Sponsor: Zagazig University

Source Zagazig University
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: The sample size was calculated using OPEN EPI program assuming that the mean postoperative opioid intake among dexmedetomidine group was 0.3±0.2 mg/kg and among lidocaine group was 0.58± 0.4 so at power of study 80% confidence interval 95%, the sample size was calculated to be 42 cases (21in each group ).

Overall Status Not yet recruiting
Start Date October 1, 2020
Completion Date August 1, 2021
Primary Completion Date July 1, 2021
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Total fentanyl consumption. up to 12 hour postoperative
Secondary Outcome
Measure Time Frame
pain intensity 30 minutes, at 1, 2, 4, 6, 8, 10, 12 hours postoperative
level of sedation up to 2 hours postoperative
Time to first call for rescue analgesic (fentanyl) up to 12 hours postopersative
Total amount of fentanyl consumption up to 12 hours postoperative
Post-operative nausea and vomiting up to 12 hours postoperative
The duration of Post Anesthesia Care Unite stay up to 2 hour postoperative
side-effects up to 12 hour postoperative
Enrollment 42
Condition
Intervention

Intervention Type: Drug

Intervention Name: Dexmedetomidine injection

Description: receive IV bolus dose of 0.5 ug/kg dexmedetomidine diluted in 10ml saline 1% over ten minutes followed by continuous infusion of 0.5 ug/kg/h

Arm Group Label: dexmedetomdine

Other Name: precedex

Intervention Type: Drug

Intervention Name: Lidocaine Iv

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

Arm Group Label: lidocaine

Other Name: xylocaine 1%

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 2-3 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.

Gender: All

Minimum Age: 6 Years

Maximum Age: 18 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Alshaimaa Kamel, M.D Principal Investigator Zagazig University
Overall Contact

Last Name: Alshaimaa Kamel, M.D

Phone: 01005593169

Phone Ext.: 002

Email: [email protected]

Location
Facility: Contact: Investigator: Zagazig University, Faculty of medicine Alshaimaa Kamel, M.D 01005593169 002 [email protected] Alshaimaa Kamel, M.D Principal Investigator
Location Countries

Egypt

Verification Date

August 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Zagazig University

Investigator Full Name: Alshaimaa Abdel Fattah Kamel

Investigator Title: lecturer of Anaesthesia ,and surgical intensive care

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: dexmedetomdine

Type: Active Comparator

Description: IV bolus dose of 0.5ug/kg dexmedetomidine diluted in 10ml saline 1% over ten minutes followed by continuous infusion of 0.5ug/kg/h

Label: lidocaine

Type: Active Comparator

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov