Anesthesia, Local
Conditions
Keywords
thoracic surgeries, pediatric caudal, dexmedetomidine
Brief summary
The aim of this study is to compare the duration of postoperative analgesia, and any side effects of caudal dexmedetomidine versus morphine in combination with bupivacaine in pediatric patients undergoing thoracic surgeries.
Detailed description
The patients will be randomized in a blinded fashion to get enrolled into 2 equal groups: Group A patients (n =25) will receive caudal epidural analgesia using dexmedetomidine with bupivacaine, whereas Group B patients (n = 25) will receive caudal epidural analgesia using morphine with bupivacaine. Randomization will be achieved by using an online random number generator. Patient codes will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. An anesthesia resident not involved in patient management will be responsible for opening the envelope. The anesthesia resident will prepare the study drug according to the instructions contained within each envelope and give it to the anesthesiologist.
Interventions
DRUGDexmedetomidine
Caudal block with Dexametomedine as an adjuvant to bupivacaine.
DRUGMorphine
Addition of morphine as adjuvant to bupivacaine during caudal block.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Randomization will be achieved by a statistician using an online random number generator. Patient codes will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. An anesthesia resident not involved in patient management will be responsible for opening the envelope. The anesthesia resident will prepare the study drug according to the instructions contained within each envelope and give it to the anesthesiologist.
Eligibility
Sex/Gender
ALL
Age
1 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* ASA I, II, III. * Patients undergoing lung cyst excision. * Patients undergoing Patent Ductus Arteriosus ligation.
Exclusion criteria
* Preoperative mechanical ventilation. * Preoperative inotropic support * History of mental retardation or delayed development that may interfere with pain intensity assessment * Known or suspected coagulopathy, * Any congenital anomalies of the sacrum or any infection at the site of injection. * Known or suspected allergy to any of the studied drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of postoperative analgesia in hours. | 3 months | Duration of postoperative analgesia in hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption in the first 24 hours post- operative. | 3 months | Opioid consumption in the first 24 hours post- operative. |
| The duration of ICU stay in days | 3 months | The duration of ICU stay in days |
| Pain score FLACC from 0 to 6 | 3 months | Pain score FLACC from 0 to 6 |
| Post operative heart rate | 3 months | Postoperative heart rate in beat per minute |
Countries
Egypt
Outcome results
None listed