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The aim of this prospective randomized double-blind study was to compare the analgesic efficacy and the side effects of dexmedetomidine (1 µg.kg-1) co-administered with bupivacaine for caudal analgesia or intravenously in children undergoing infra-umbilical surgery.
Dexmedetomidine is used increasingly in pediatric anesthesia practice to prolong the duration of action of caudal block with a local anesthetic agent.But which route of administration of dexmedetomidine is the most beneficial remains unknown.
The investigators performed prospective randomized double-blind study to compare the effects of caudal dexmedetomidine with intravenous dexmedetomidine on postoperative analgesia after caudal bupivacaine in children undergoing infra-umbilical surgery.
75 children (ASAⅠorⅡ,aged 1-6 yr) undergoing infra-umbilical surgery were included in this study. Anesthesia was induced with sevoflurane via a facemask, followed by placement of a laryngeal mask airway. Anesthesia was maintained with sevoflurane 2-3% in oxygen-air.Then,caudal block was applied. Patients were randomly assigned in three groups. Group B-Dcau (n = 25): Caudal bupivacaine 0.25% 1ml/kg plus dexmedetomidine 1µg/kg and 10 ml normal saline i.v.;Group B-Div (n = 25): bupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg(10 ml)i.v.;Group B(n = 25): bupivacaine 0.25% and 10 ml normal saline intravenous
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| caudal Dexmedetomidine | Active Comparator | Drug:Caudal Bupivacaine 0.25% 1ml/kg . Drug:caudal Dexmedetomidine 1μg /kg. Intravenous :10 ml normal saline Anesthesia was induced and maintained with sevoflurane |
|
| Intravenous Dexmedetomidine | Active Comparator | Drug:Caudal bupivacaine 0.25% 1ml/kg Drug: Intravenous dexmedetomidine 1µg/kg in a 10 ml volume normal saline Anesthesia was induced and maintained with sevoflurane |
|
| Placebo | Placebo Comparator | Caudal: bupivacaine 0.25% 1ml/kg . Intravenous: 10 ml Normal saline Anesthesia was induced and maintained with sevoflurane |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caudal Dexmedetomidine | Drug | Drug:Caudal bupivacaine 0.25% 1ml/kg Drug: Caudal dexmedetomidine 1µg/kg Intravenous: 10 ml normal saline sevoflurane Induction and maintenance of anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first analgesic requirement | Time to first rescue medication. The time from end of surgery to the first requirement of postoperative analgesia,pain score ≥4 | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative behaviour scores | behaviour score was recorded throughout the post-anesthesia care unit stay at 15-minute time intervals. | 2 hours |
| Sevoflurane concentration | Sevoflurane concentration required to maintain Bispectral Index (BIS) monitor reading between 40 and 60 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| khaled R Al-zaben | University of Jordan | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24932765 | Background | Zhang C, Hu J, Liu X, Yan J. Effects of intravenous dexmedetomidine on emergence agitation in children under sevoflurane anesthesia: a meta-analysis of randomized controlled trials. PLoS One. 2014 Jun 16;9(6):e99718. doi: 10.1371/journal.pone.0099718. eCollection 2014. | |
| 16101707 | Background | Guler G, Akin A, Tosun Z, Ors S, Esmaoglu A, Boyaci A. Single-dose dexmedetomidine reduces agitation and provides smooth extubation after pediatric adenotonsillectomy. Paediatr Anaesth. 2005 Sep;15(9):762-6. doi: 10.1111/j.1460-9592.2004.01541.x. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Intravenous dexmedetomidine | Drug | Drug:Caudal bupivacaine 0.25% 1ml/kg. Drug:Intravenous dexmedetomidine1 μg /kg in a total volume of 10 ml sevoflurane Induction and maintenance of anesthesia |
|
|
| Placebo | Drug | Drug:Caudal bupivacaine 0.25% 1ml/kg Intravenous: Normal saline 10 ml sevoflurane Induction and maintenance of anesthesia |
|
|
| 1 hour |
| Blood pressure Perioperative blood pressure readings | Perioperative blood pressure readings | 2 hours |
| Heart Rate | Perioperative heart rate readings | 2 hours |
| the incidence of emergence agitation | Participants will be followed for the duration of PACU stay, an expected average of 2 hours | 2 hours |
| Postoperative pain scores | postoperative pain score will be assessed over 24 hours | 24 hours |
| Side effects | side effects including nausea, vomiting and urinary retention and lower limb weakness | 24 hours |
| 19952754 | Background | Al-Zaben KR, Qudaisat IY, Al-Ghanem SM, Massad IM, Al-Mustafa MM, Al-Oweidi AS, Abu-Halaweh SA, Abu-Ali HM, Saleem MM. Intraoperative administration of dexmedetomidine reduces the analgesic requirements for children undergoing hypospadius surgery. Eur J Anaesthesiol. 2010 Mar;27(3):247-52. doi: 10.1097/EJA.0b013e32833522bf. |
| 24339309 | Background | Kim NY, Kim SY, Yoon HJ, Kil HK. Effect of dexmedetomidine on sevoflurane requirements and emergence agitation in children undergoing ambulatory surgery. Yonsei Med J. 2014 Jan;55(1):209-15. doi: 10.3349/ymj.2014.55.1.209. |
| 25468576 | Background | She YJ, Xie GT, Tan YH, Kuang XH, Yu GF, Lian GH, Song XR. A prospective study comparing the onset and analgesic efficacy of different concentrations of levobupivacaine with/without dexmedetomidine in young children undergoing caudal blockade. J Clin Anesth. 2015 Feb;27(1):17-22. doi: 10.1016/j.jclinane.2014.09.005. Epub 2014 Nov 21. |
| 23043461 | Background | Schnabel A, Reichl SU, Poepping DM, Kranke P, Pogatzki-Zahn EM, Zahn PK. Efficacy and safety of intraoperative dexmedetomidine for acute postoperative pain in children: a meta-analysis of randomized controlled trials. Paediatr Anaesth. 2013 Feb;23(2):170-9. doi: 10.1111/pan.12030. Epub 2012 Oct 9. |
| 25247897 | Background | Fares KM, Othman AH, Alieldin NH. Efficacy and safety of dexmedetomidine added to caudal bupivacaine in pediatric major abdominal cancer surgery. Pain Physician. 2014 Sep-Oct;17(5):393-400. |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |