Intraperitoneal Analgesia in Pediatric Laparoscopy

Assiut University

Status and phase: Completed; Phase 2

Conditions: Analgesia

Treatments: Drug: Magnesium Sulfate; Drug: Dexmedetomidine; Drug: Normal saline 0.9 %

Study type: Interventional

Funder types: Other

Identifiers

NCT02820610

SM62016

Details and patient eligibility

About

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

Full 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.

Enrollment: 97 patients

Sex: Male

Ages: 1 to 6 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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97 participants in 3 patient groups, including a placebo group

Dexmedetomidine

Active Comparator group

Description:

2 mg/kg bupivacaine 0.5% and 1 ug/kg of dexamedetomidine diluted in normal saline 0.9 % will instilled into the peritoneal cavity

Treatment:

Drug: Dexmedetomidine

Magnesium sulfate

Active Comparator group

Description:

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

Treatment:

Drug: Magnesium Sulfate

Control group

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal saline 0.9 %