Infra-orbital Nerve Block for Post Operative Analgesia in Children Undergoing Cleft Lip Surgery.

NCT02514980 | Completed Phase 2 DMC

• 1 other identifier: IRB00008718/ ref. no.103
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

this study will be undertaken to evaluate the safety and analgesic efficacy of adding ketamine to bupivacaine in bilateral infra-orbital nerve block for relief of pain postoperatively following repair of cleft lip in children less than two years of age.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• postoperative analgesic consumption

  the total consumption of analgesics in the first 24h postoperative

  24 hours postoperative

Secondary Outcomes (2)

• Postoperative The Face, Legs, Activity, Cry, Consolability ( FLACC) pain score

  24 h postoperative.

• Parent satisfaction score

  24 h postoperative

Study Arms (2)

Bupivacaine group

ACTIVE COMPARATOR

Infraorbital nerve block using bupivacaine 0.25% on each side.

Drug: Bupivacaine

Bupivacaine-Ketamine group.

ACTIVE COMPARATOR

Infraorbital nerve block using bupivacaine 0.25% combined with 0.5mg/kg ketamine on each side.

Drug: Bupivacaine; Drug: Ketamine

Interventions

Bupivacaine DRUG

Infraorbital nerve block using bupivacaine 0.25% on each side.

Also known as: bucaine

Bupivacaine group; Bupivacaine-Ketamine group.

Ketamine DRUG

Infraorbital nerve block using 0.5mg/kg ketamine on each side.

Also known as: Katalar

Bupivacaine-Ketamine group.

Eligibility Criteria

• Age: 3 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• (ASA) physical status I and II aged less than 2 years undergoing elective cleft lip repair (with or without cleft palate) under general anesthesia.

You may not qualify if:

• Patients with local infection at the site of injection of block, history suggestive of drug allergy, any systemic disease that compromises the cardiovascular, respiratory or neurological function, other congenital anomaly, history of upper or lower airway disease, coagulation disorders, and children with history of sleep apnea and in whom postoperative ventilation may be required will be excluded from the study.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospitals

Asyut, Assiut Governorate, 715715, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Ketamine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Hala S Abdel-Ghaffar, MD

  Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 1, 2015
• First Posted: August 4, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 31, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)