- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02820610
Intraperitoneal Analgesia in Pediatric Laparoscopy
Dexmedetomidine Versus Magnesium Sulfate as an Adjuvant to Intraperitoneal Bupivacaine for Pain Relief in Children Undergoing Laparoscopic Herniorrhaphy: a Randomized Controlled Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Assuit
-
Asyut, Assuit, Egypt, 71516
- faculty of medicine assuit university
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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,
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Dexmedetomidine
2 mg/kg bupivacaine 0.5% and 1 ug/kg of dexamedetomidine diluted in normal saline 0.9 % will instilled into the peritoneal cavity
|
2 mg/kg bupivacaine 0.5% and 1 ug/kg of dexamedetomidine diluted in normal saline 0.9 % will instilled into the peritoneal cavity
Other Names:
|
Active Comparator: Magnesium sulfate
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
|
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
|
Placebo Comparator: Control group
2 mg/kg bupivacaine 0.5% diluted in normal saline 0.9 % will instilled into the peritoneal cavity.
|
2 mg/kg bupivacaine 0.5% diluted in normal saline 0.9 % will instilled into the peritoneal cavity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative pain
Time Frame: 48 hr
|
The Face Legs Activity Cry and Consolability (FLACC) pain score
|
48 hr
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the functional recovery
Time Frame: 48 hours after surgery
|
the functional activity score (FAS)
|
48 hours after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Membrane Transport Modulators
- Hypnotics and Sedatives
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Dexmedetomidine
- Magnesium Sulfate
Other Study ID Numbers
- SM62016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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