Intraperitoneal Analgesia in Pediatric Laparoscopy

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02820610
• Other study ID #: SM62016
• Status: Completed
• Phase: Phase 2
• Start date: August 2016
• Est. completion date: September 2019

Study information

• Verified date: January 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 1 Year to 6 Years

Eligibility

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,

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• 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
• 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
• Normal saline 0.9 %
2 mg/kg bupivacaine 0.5% diluted in normal saline 0.9 % will instilled into the peritoneal cavity.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Assuit University	Asyut	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	The Face Legs Activity Cry and Consolability (FLACC) pain score	48 hr
Secondary	the functional recovery	the functional activity score (FAS)	48 hours after surgery