Topical Ketamine Versus Caudal Ketamine for Postoperative Analgesia in Children Undergoing Inguinal Herniotomy

NCT02462174 | Completed Phase 2 DMC

• 1 other identifier: IRB00008718/ NF
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

To find alternatives to caudal analgesia that could be more safe and effective and to demonstrate the analgesic efficacy of topical ketamine.

Conditions

Postoperative Pain

Keywords

anesthesia; analgesia; caudal; ketamine; bupivacaine

Outcome Measures

Primary Outcomes (1)

• time to first request for postoperative analgesia

  time in hours from admission to PACU till first request for analgesia

  48 hours postoperative

Secondary Outcomes (8)

• total consumption of postoperative analgesics

  48 hours postoperative

• The Children's Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10) pain score

  180 minutes postoperative

• Faces Legs Activity Cry Consolability tool (FLACC, 0-10).

  180 minutes postoperative.

• the agitation score (0= child is asleep, 1= awake/calm, 2= irritable/ consolable cry, 3=inconsolable cry, 4= the child is agitating and thrashing and restlessness).

  60 minutes postoperative

• parent's satisfaction on a four-point Likert scale (1, excellent; 2, good; 3, fair; 4, poor).

  48 hours postoperative

Study Arms (2)

Topical ketamine and topical bupivacaine

ACTIVE COMPARATOR

0.5 mg/ kg ketamine in 0.3 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) administered directly around the spermatic cord in the wound after end of surgery and before closure of the wound.

Drug: Ketamine; Drug: Bupivacaine

Caudal ketamine and caudal bupivacaine

ACTIVE COMPARATOR

0.5 mg/ kg ketamine in 1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) administered by caudal epidural route after anesthesia and before the start of surgery.

Drug: Ketamine; Drug: Bupivacaine

Interventions

Ketamine DRUG

0.5 mg/ kg ketamine with bupivacaine by caudal route after anesthesia and before start of surgery.

Also known as: Katalar

Topical ketamine and topical bupivacaine

Bupivacaine DRUG

1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) by caudal route

Also known as: bucaine

Topical ketamine and topical bupivacaine

Eligibility Criteria

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

You may qualify if:

• age (6 months to 6 years)
• ASA physical status I or II.
• Operation: elective unilateral inguinal herniotomy.

You may not qualify if:

• A history of developmental delay or mental retardation,
• Known or suspected coagulopathy,
• Known allergy to any local anaesthetic,
• Known congenital anomaly of the spine or signs of spinal anomaly,
• Infection at the sacral region.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospitals

Asyut, Assiut Governorate, 715715, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Ketamine; Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

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

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: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor anesthesia and intensive care department/ faculty of medicine/ Assiut university/ Egypt.

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: June 3, 2015
• Study Start: May 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 2, 2015

Record last verified: 2015-10

Locations

EG (1)