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.
1 other identifier
interventional
97
1 country
1
Brief Summary
It is important to keep children undergoing laparoscopic surgery pain free with rapid return to normal activity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2016
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2016
CompletedFirst Posted
Study publicly available on registry
July 1, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedJanuary 3, 2020
January 1, 2020
3.1 years
June 29, 2016
January 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative pain
The Face Legs Activity Cry and Consolability (FLACC) pain score
48 hr
Secondary Outcomes (1)
the functional recovery
48 hours after surgery
Study Arms (3)
Dexmedetomidine
ACTIVE COMPARATOR2 mg/kg bupivacaine 0.5% and 1 ug/kg of dexamedetomidine diluted in normal saline 0.9 % will instilled into the peritoneal cavity
Magnesium sulfate
ACTIVE COMPARATOR2 mg/kg bupivacaine 0.5% and 30 mg/kg of magnesium sulfate diluted in normal saline 0.9 % will instilled into the peritoneal cavity
Control group
PLACEBO COMPARATOR2 mg/kg bupivacaine 0.5% diluted in normal saline 0.9 % will instilled into the peritoneal cavity.
Interventions
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 30 mg/kg of magnesium sulfate 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.
Eligibility Criteria
You may qualify if:
- age (1 to 6 years)
- ASA physical status I or II.
- scheduled for laparoscopic hernia repair under general anesthesia.
You may not qualify if:
- Allergy to study drugs,
- Receiving chronic pain treatment, antiepileptic therapy or magnesium therapy,
- sever hepatic or renal impairment,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine Assuit University
Asyut, Assuit, 71516, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer
Study Record Dates
First Submitted
June 29, 2016
First Posted
July 1, 2016
Study Start
August 1, 2016
Primary Completion
September 1, 2019
Study Completion
September 1, 2019
Last Updated
January 3, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will share