Intraperitoneal Analgesia in Pediatric Laparoscopy

Phase 2

Completed

• Conditions: Analgesia
• Interventions: Drug: Magnesium Sulfate; Drug: Normal saline 0.9 %; Drug: Dexmedetomidine

• Registration Number: NCT02820610
• Lead Sponsor: Assiut University

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-06-29
• Study First Submitted QC: 2016-06-30
• Study First Posted: 2016-07-01
• Study Start: 2016-08
• Primary Completion: 2019-09
• Study Completion: 2019-09
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-01
• Last Update Posted: 2020-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 97

Inclusion Criteria

1. age (1 to 6 years)
2. ASA physical status I or II.
3. scheduled for laparoscopic hernia repair under general anesthesia.

Exclusion Criteria

1. Allergy to study drugs,
2. Receiving chronic pain treatment, antiepileptic therapy or magnesium therapy,
3. sever hepatic or renal impairment,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnesium sulfate	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
Control group	Normal saline 0.9 %	2 mg/kg bupivacaine 0.5% diluted in normal saline 0.9 % will instilled into the peritoneal cavity.
Dexmedetomidine	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

Primary Outcome Measures

Name	Time	Method
Postoperative pain	48 hr	The Face Legs Activity Cry and Consolability (FLACC) pain score

Secondary Outcome Measures

Name	Time	Method
the functional recovery	48 hours after surgery	the functional activity score (FAS)

Trial Locations

Locations (1)

Faculty of Medicine Assuit University; 🇪🇬 Asyut, Assuit, Egypt