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This study is being done to find out which medicine combination provides better pain relief after surgery in children. Children who are having surgery below the belly button (called infra-umbilical surgery) will receive general anesthesia and a type of pain-blocking injection called a caudal block. This block helps reduce pain after surgery.
The study will compare two types of caudal injections:
One group will receive Bupivacaine alone, a commonly used local anesthetic.
The other group will receive Bupivacaine combined with Dexmedetomidine, a medicine that might help the pain relief last longer.
The main question the researchers want to answer is:
Does adding Dexmedetomidine to Bupivacaine increase the duration of pain relief after surgery in children?
Researchers will also look at:
How long it takes before the child needs the first dose of pain medicine after surgery
How much pain medicine is used in the first 24 hours
How long any movement problems (motor block) last
Whether there are any side effects
Each child will be randomly assigned (like flipping a coin) to one of the two groups. The caudal block will be done after the surgery is completed, while the child is still under anesthesia. The nurse assessing the child's pain will not know which medicine the child received.
Children will be monitored for pain using a standard scoring system (FLACC scale) every few hours after surgery. If the pain score is high (7 or more), the child will receive intravenous paracetamol. Researchers will record how long the pain relief lasts, when the first pain medicine is needed, and the total amount of pain medicine used in the first 24 hours.
The study aims to help doctors choose the most effective and safe method to reduce post-surgery pain in children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy | Active Comparator | Bupivacaine alone |
|
| Combination therapy | Experimental | Bupivacaine with Dexmedetomidine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine %0.25 (isobaric) | Drug | 1 ml/kg of 0.25% Bupivacaine will be used for caudal block. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Analgesia Duration | Duration of post-operative pain free time (hours): time from surgery to FLACC score ≥7 needing rescue analgesia | From surgery to 24-hours post operatively |
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| Measure | Description | Time Frame |
|---|---|---|
| Analgesia Consumption | Total amount (milligrams) of paracetamol consumed | From surgery to 24-hours post operatively |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Syed A Abbas Naqvi, FCPS | Allama Iqbal Teaching Hospital Dera Ghazi Khan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allama Iqbal Teaching Hospital | Dera Ghazi Khan | Punjab Province | 32200 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19076110 | Background | Saadawy I, Boker A, Elshahawy MA, Almazrooa A, Melibary S, Abdellatif AA, Afifi W. Effect of dexmedetomidine on the characteristics of bupivacaine in a caudal block in pediatrics. Acta Anaesthesiol Scand. 2009 Feb;53(2):251-6. doi: 10.1111/j.1399-6576.2008.01818.x. Epub 2008 Dec 6. | |
| 27212752 | Background | Goyal V, Kubre J, Radhakrishnan K. Dexmedetomidine as an adjuvant to bupivacaine in caudal analgesia in children. Anesth Essays Res. 2016 May-Aug;10(2):227-32. doi: 10.4103/0259-1162.174468. |
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| Dexmedetomidine & Bupivacaine. | Drug | 1 ml/kg of 0.25% Bupivacaine PLUS 1 μg/kg Dexmedetomidine in 1 ml Normal Saline will be used for caudal block. |
|
| ID | Term |
|---|---|
| D007021 | Hypospadias |
| ID | Term |
|---|---|
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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