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| ID | Type | Description | Link |
|---|---|---|---|
| FujianPH-TRC-121002 | Registry Identifier | Fujian Provicial Hospital |
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| Name | Class |
|---|---|
| West China Hospital | OTHER |
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The purpose of this study is to compare the effects of caudal dexmedetomidine with intravenous dexmedetomidine on caudal levobupivacaine analgesia in children undergoing lower abdominal surgeries.
Single shot caudal epidural block is one of the most widespread technique for pediatric pain management after infraumbilical surgical procedures.However, in a significant proportion of patients, despite good initial analgesia from a caudal block with local anesthetic, pain develops after the block resolves.
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 clonidine 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 levobupivacaine for inguinal herniorrhaphy or orchidopexy surgery.
90 children (ASAⅠorⅡ,aged 2-5 yr) undergoing unilateral orchiopexy or inguinal herniorrhaphy 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 Cau-DEX (n = 30): Caudal Levobupivacaine 0.25% 1ml/kg plus dexmedetomidine 1µg/kg and 10 ml normal saline i.v.;Group IV-DEX(n = 30): Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg(10 ml)i.v.;Group Placebo(n = 30): Levobupivacaine 0.25% and 10 ml normal saline intravenous.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caudal Dexmedetomidine | Experimental | Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg Intravenous: 10 ml normal saline Anesthesia was induced and maintained with sevoflurane |
|
| Intravenous Dexmedetomidine | Experimental | Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: dexmedetomidine 1µg/kg Anesthesia was induced and maintained with sevoflurane |
|
| Placebo | Placebo Comparator | Caudal: Levobupivacaine 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 | Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg Intravenous: 10 ml normal saline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to first rescue medication | the Children and Infants Postoperative Pain Scale (CHIPPS) | From the administration of the caudal block to the first registration of a CHIPPS scores≥4,assessed up to 24h |
| Measure | Description | Time Frame |
|---|---|---|
| the number of patients not requiring rescue analgesia | the quality of postoperative pain control | After surgery,up to 24h |
| the sedation score | sedation was assessed using the Modified Ramsay Sedation Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yusheng Yao, M.D. | Fujian Provincial Hospital | Principal Investigator |
| Yanqing Chen, M.D. | Fujian Provicial Hospital | Principal Investigator |
| Jin Liu, M.D. | West China Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Provincial Hospital | Fuzhou | Fujian | 350001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30302881 | Derived | Yao Y, Yu C, Zhang X, Guo Y, Zheng X. Caudal and intravenous dexmedetomidine similarly prolong the duration of caudal analgesia in children: A randomized controlled trial. Paediatr Anaesth. 2018 Oct;28(10):888-896. doi: 10.1111/pan.13469. |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D003456 | Cryptorchidism |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077554 | Levobupivacaine |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Intravenous Dexmedetomidine | Drug | Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: dexmedetomidine 1µg/kg |
|
|
| Placebo | Drug | Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: 10 ml normal saline |
|
|
| sevoflurane | Drug | Induction and maintain anaesthesia |
|
| After surgery, every 15min for the first 2 h, every 30min for the next 2h, hourly for the next 4h |
| Residual motor block | the degree of motor blockade was assessed using a modified Bromage scale | After awake,participants will be followed every 30min for the first 2h, hourly for the next 4h |
| the incidence of emergence agitation | The incidence of emergence agitation was evaluated by the Pediatric Anesthesia Emergence Delirium Scale(PAED) | Participants will be followed for the duration of PACU stay, an expected average of 2 hours |
| side effects | side effects including bradycardia, hypotension, hypoxemia, nausea, vomiting and urinary retention | From the administration of the caudal block until the end of study period, assessed up to postoperative 24h |
| Pain intensity | Participants will be assessed with Children and Infants Postoperative Pain Scale (CHIPPS) | after surgery, 30min for first 4h, hourly for the next 4h and thereafter every 2h,assessed up to 24h |
| D013733 | Testicular Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014564 | Urogenital Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D002045 |
| Bupivacaine |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |