Clinical trial NCT04445636: Efficacy of Dexmedetomidine Versus Morphine as an Adjunct to Bupivacaine in Caudal Anesthesia.
Official title: Efficacy of Dexmedetomidine Versus Morphine as an Adjunct to Bupivacaine in Caudal Anesthesia for Pediatric Thoracic Surgeries. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Local
Keywords: thoracic surgeries
pediatric caudal
dexmedetomidine
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Duration of postoperative analgesia in hours.
timeFrame: 3 months
Secondary outcomes:
measure: Opioid consumption in the first 24 hours post- operative.
timeFrame: 3 months
measure: The duration of ICU stay in days
timeFrame: 3 months
measure: Pain score FLACC from 0 to 6
timeFrame: 3 months
measure: Post operative heart rate
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Hospitals
Study officials:
affiliation: Cairo University Hospitals
name: AHMED ISMAIL, Lecturer
role: STUDY_DIRECTOR
References:
citation: Anand VG, Kannan M, Thavamani A, Bridgit MJ. Effects of dexmedetomidine added to caudal ropivacaine in paediatric lower abdominal surgeries. Indian J Anaesth. 2011 Jul;55(4):340-6. doi: 10.4103/0019-5049.84835.
citation: El Shamaa HA, Ibrahim M. A comparative study of the effect of caudal dexmedetomidine versus morphine added to bupivacaine in pediatric infra-umbilical surgery. Saudi J Anaesth. 2014 Apr;8(2):155-60. doi: 10.4103/1658-354X.130677.
citation: Nguyen KN, Byrd HS, Tan JM. Caudal analgesia and cardiothoracic surgery: a look at postoperative pain scores in a pediatric population. Paediatr Anaesth. 2016 Nov;26(11):1060-1063. doi: 10.1111/pan.12990. Epub 2016 Aug 23.