Perioperative Pain Management for Cleft Lip in Children

Cairo University (CU)

Status: Unknown

Conditions: Perioperative Complication Pain

Treatments: Drug: Bupivacain; Combination Product: i.v. analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT04614259

N 49-2018/Ms

Details and patient eligibility

About

Single blind prospective randomized comparative study. 76 children between 6 months and 3 years with cleft lip will be divided in two groups. 38 children group C conventional group and 38 children group S infraorbital nerve block group.

Enrollment: 76 estimated patients

Sex: All

Ages: 6 months to 3 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• good physical condition.
• Age 6 months to 3 years.
• Scheduled to undergo operations for cleft lip repair. Genders eligible for study are both .

Exclusion criteria

• Children posted for combined procedures like congenital heart correction with palatoplasty .
• Parents refusal .
• Bleeding disorders( platelets count < 100.000 , international ratio >1.5).
• Skin lesions or wounds at site of needle insertion .
• Co-morbidities as congenital heart disease , lung pathology or central nervous system
• Known hypersensitivity to local anesthetics or opioids .

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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76 participants in 2 patient groups

intravenous analgesia

Experimental group

Treatment:

Combination Product: i.v. analgesia

infraorbital nerve block

Experimental group

Treatment:

Drug: Bupivacain