Intraperitoneal Analgesia in Pediatric Laparoscopy

Study Overview
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Brief Summary
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It is important to keep children undergoing laparoscopic surgery pain free with rapid return to normal activity.

Detailed Description
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Pain following laparoscopy is less intense than after laparotomy. Nevertheless, laparoscopy is not pain free and control of post-laparoscopy pain remains a major concern. The exact cause of such pain remains uncertain, and yet, diaphragmatic irritation and peritoneal stretching associated with gas insufflation may be responsible for shoulder and diffuse abdominal pain. additionally poor pain control could limit the activity of children following laparoscopic surgery.

Official Title
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Dexmedetomidine Versus Magnesium Sulfate as an Adjuvant to Intraperitoneal Bupivacaine for Pain Relief in Children Undergoing Laparoscopic Herniorrhaphy: a Randomized Controlled Study.

Conditions
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Analgesia

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Magnesium Sulfate
* Drug: Normal saline 0.9 %


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age (1 to 6 years) ASA physical status I or II. scheduled for laparoscopic hernia repair under general anesthesia. Exclusion Criteria: Allergy to study drugs, Receiving chronic pain treatment, antiepileptic therapy or magnesium therapy, sever hepatic or renal impairment,

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 6 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine<br>2 mg/kg bupivacaine 0.5% and 1 ug/kg of dexamedetomidine diluted in normal saline 0.9 % will instilled into the peritoneal cavity | Drug: Dexmedetomidine<br>* 2 mg/kg bupivacaine 0.5% and 1 ug/kg of dexamedetomidine diluted in normal saline 0.9 % will instilled into the peritoneal cavity<br>* Other names: Presidx;|
| Active Comparator: Magnesium sulfate<br>2 mg/kg bupivacaine 0.5% and 30 mg/kg of magnesium sulfate diluted in normal saline 0.9 % will instilled into the peritoneal cavity | Drug: Magnesium Sulfate<br>* 2 mg/kg bupivacaine 0.5% and 30 mg/kg of magnesium sulfate diluted in normal saline 0.9 % will instilled into the peritoneal cavity<br>|
| Placebo Comparator: Control group<br>2 mg/kg bupivacaine 0.5% diluted in normal saline 0.9 % will instilled into the peritoneal cavity. | Drug: Normal saline 0.9 %<br>* 2 mg/kg bupivacaine 0.5% diluted in normal saline 0.9 % will instilled into the peritoneal cavity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | The Face Legs Activity Cry and Consolability (FLACC) pain score | 48 hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the functional recovery | the functional activity score (FAS) | 48 hours after surgery |