Procedural Sedation and Analgesia During Bone Marrow Aspiration and Biopsy
Conditions
Brief summary
Group I :The patients will receive midazolam intravenously (i.v.) in a dose of 0.05 mg/kg diluted by 50ml saline over 10 minutes using syringe pump plus 1 mg/kg ketamine (iv). Group II : The patients will receive Dexmedetomidine intravenously (i.v.) in a dose of 2mic/kg diluted by 50ml saline over 10 minutes using syringe pump plus 1 mg/kg ketamine (iv). The objective of this study to evaluate the clinical effects, adverse effects and recovery time of two different sedative agents (midazolam and Dexmedetomidine) combined with ketamine during conscious sedation for child patient with haematological cancer undergoing BMA &biopsy.
Interventions
DRUGmidazolam intravenous infusion of 0.05 mg/kg plus 1 mg/kg ketamine
midazolam intravenously (i.v.) in a dose of 0.05 mg/kg diluted by 50ml saline over 10 minutes using syringe pump plus 1 mg/kg ketamine
DRUGDexmedetomidine intravenous infusion of 2mic/kg plus 1 mg/kg ketamine
Dexmedetomidine intravenously (i.v.) in a dose of 2mic/kg diluted by 50ml saline over 10 minutes using syringe pump plus 1 mg/kg ketamine
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* All consecutive children with acute lymphoblastic leukemia undergoing bone marrow aspiration and biopsy.
Exclusion criteria
* previous sensitization or anaphylactic reaction to Dexmedetomidine, ketamine,and midazolam; * evidence of head injury, * raised intracranial or intraocular tension; * use of drugs known to interact with either study agent; * an American Society of Anesthesiologists (ASA) physical status score greater than 2. * Also Patients with cardiovascular, respiratory, hepatic diseases and epilepsy will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| efficacy of drug mixture on procedural sedation and analgesia: Ramsay sedation score | within the time of the procedure of bone marrow aspirate and biopsy | to assess efficacy of procedural sedation and analgesia with drug mixture;using Ramsay sedation score. Ramsay score 1. Nervous, agitated, and/or restless. 2. Cooperative, orientated, quite patient. 3. Only obeying orders. 4. Sleeping, hitting the glabella, and responding to high voice suddenly 5. Sleeping, hitting the glabella, and responding to high voice slowly 6. No response to any of these stimulations Dexemeditomidine and midazolam will be started 2 minutes before procedure through a peripheral venous cannula and continued as maintainance, then ketamine will be administered over 10-20 s aiming to achieve a sedation level of 3 or 4 on Ramsay scale to start the procedure. |
Countries
Egypt
Outcome results
None listed