Intraperitoneal Analgesia in Pediatric Laparoscopy

NCT ID: NCT02820610

Last Updated: 2020-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2019-09-30

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.

Conditions

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Magnesium Sulfate

Intervention Type DRUG

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

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

Group Type PLACEBO_COMPARATOR

Normal saline 0.9 %

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

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

Intervention Type DRUG

Normal saline 0.9 %

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

Intervention Type DRUG

Other Intervention Names

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Presidx

Eligibility Criteria

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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,
Minimum Eligible Age

1 Year

Maximum Eligible Age

6 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Seham Mohamed Moeen Ibrahim

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine Assuit University

Asyut, Assuit, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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SM62016

Identifier Type: -

Identifier Source: org_study_id

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