Intraperitoneal Analgesia in Pediatric Laparoscopy

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02820610

Enrollment

Registered

2016-07-01

Start date

2016-08-31

Completion date

2019-09-30

Last updated

2020-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia

Brief summary

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

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.

Interventions

DRUGDexmedetomidine

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

DRUGMagnesium 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

DRUGNormal saline 0.9 %

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

1 Years to 6 Years

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,

Design outcomes

Primary

Measure	Time frame	Description
Postoperative pain	48 hr	The Face Legs Activity Cry and Consolability (FLACC) pain score

Secondary

Measure	Time frame	Description
the functional recovery	48 hours after surgery	the functional activity score (FAS)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026