Intraperitoneal Analgesia in Pediatric Laparoscopy

January 1, 2020 updated by: Seham Mohamed Moeen Ibrahim, Assiut University

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

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

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

97

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Assuit
      • Asyut, Assuit, Egypt, 71516
        • Faculty of Medicine Assuit University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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
Other Names:
  • Presidx
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
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
Placebo Comparator: Control group
2 mg/kg bupivacaine 0.5% diluted in normal saline 0.9 % will instilled into the peritoneal cavity.
Drug: Normal saline 0.9 %
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

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

June 29, 2016

First Submitted That Met QC Criteria

June 30, 2016

First Posted (Estimate)

July 1, 2016

Study Record Updates

Last Update Posted (Actual)

January 3, 2020

Last Update Submitted That Met QC Criteria

January 1, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SM62016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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