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OpenTrials
Completed

NCT Number: NCT02820610

Intraperitoneal Analgesia in Pediatric Laparoscopy

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

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Key information

Conditions

Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

1 year–6 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine Assuit University

Asyut, Assuit, 71516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Allergy to study drugs,
  • Receiving chronic pain treatment, antiepileptic therapy or magnesium therapy,
  • sever hepatic or renal impairment,

Treatment and study plan

Dexmedetomidine

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

Other names: Presidx

Magnesium sulfate

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

Normal saline 0.9 %

Drug

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

Primary outcomes

  1. Postoperative pain

    Time frame: 48 hr

    The Face Legs Activity Cry and Consolability (FLACC) pain score

Secondary outcomes

  1. the functional recovery

    Time frame: 48 hours after surgery

    the functional activity score (FAS)

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 1, 2016
Registry last updated
Jan 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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