The effect of propofol_ketamine and propofol_remifentanil for deep sedation and analgesia during painful procedures in 6 month to 14 year old children with acute lymphoblastic leukemia in sayedoshohada Medical Center in Isfahan in 2016.
- Conditions
- Acute lymphoblastic leukaemia [ALL].This code should only be used for T-cell and B-cell precursor leukeamia
- Registration Number
- IRCT2017080935601N1
- Lead Sponsor
- Isfahan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 81
The inclusion criteria were included, Children aged between Six months to fourteen years old with Hematologic Malignancies (such as acute lymphocytic leukemia) were candidates for painful intervention Lumbar Puncture; Bone marrow aspiration/Biopsy. Non-entry criteria include patients with head trauma; High intraocular pressure (IOP); or High intracranial pressure (ICP); cardiovascular or repertory or liver diseases; epilepsy or history of seizure; Neurological disorder ;tumor or metastasis of the brain; usage of analgesic or sedative drugs in before intervention; chronic pain syndrome; and not having to participate in the study; history of allergy or allergic reaction to Our study drugs Excluded criteria include any complications during intervention that causes the anesthetic program to change
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sedation Level. Timepoint: During Procedure. Method of measurement: University of Michigan Sedation Scale (UMSS).;Analgesia. Timepoint: During Procidure. Method of measurement: Universal Pain Assessment Tool (UPAT).
- Secondary Outcome Measures
Name Time Method Hemodynamic changes ( Heart rate , Systolic and Diastolic blood pressure, Mean atria pressure). Timepoint: Before And Every 5 minutes during the procedure and Every 10 minutes in recovery. Method of measurement: Cardiac monitoring and automatic blood pressure monitoring.;Arterial oxygen saturation. Timepoint: Before and every 5 minutes during the procedure and Every 10 minutes in recovery. Method of measurement: Pulse oximeter.