NCT03476772

Brief Summary

Caudal aneasthesia for pediatric surgery was first reported in 1933. Since then, studies have described the indications for pediatric caudal block, the level of analgesia, doses, advantages and disadvantages of this technique. In children, caudal anesthesia is most effectively used as adjunct to general aneasthesia and has an opioid-sparing effect, permitting faster and smoother emergence from aneasthesia. A single shot caudal anesthesia provides relatively brief analgesia for 4 to 8 hours depending on the agent used. Prolongation of anesthesia can be achieved by adding various adjuvants, such as opioids and nonopioids such as clonidine, ketamine, midazolam, and neostigmine,with varying degrees of success.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 26, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

March 24, 2021

Status Verified

March 1, 2021

Enrollment Period

2 years

First QC Date

March 9, 2018

Last Update Submit

March 21, 2021

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

  • post operative pain measurement

    Postoperative pain intensity Measured by Face, Legs, Activity, Cry \& consolability (FLACC) pain scale

    24 hours

Study Arms (2)

A

NO INTERVENTION

children undergoing hypospadius repair given 1 ml/kg of bupivicaine 0.25 % via caudal route to achieve post operative analgesia

B

ACTIVE COMPARATOR

children undergoing hypospadius repair given 1 ml/kg of bupivicaine 0.25 % plus 0.1 mg nalbuphine via caudal route to achieve post operative analgesia

Drug: Nalbuphine

Interventions

NalbuphineDRUG

Children will be randomly assigned into 2 groups of 30 patients each. They will receive caudal anesthesia using bupivacaine 0.25% 1ml/kg plus 2 ml normal saline in the control group, bupivacaine 0.25% 1ml/kg plus nalbuphine 0.1 mg/kg in 2 ml solution in the nalbuphine group.

B

Eligibility Criteria

Age2 Years - 10 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male children undergoing hypospadius repair, with an American Society of Anesthesiologists (ASA) physical status I.

You may not qualify if:

  • Guardians refusal.
  • Contraindication to caudal block such as:
  • Patients with congenital anomalies at the lower spine or meninges.
  • Patients with increased intracranial pressure.
  • Patients with skin infection at the site of injection.
  • Patients with bleeding diathesis.
  • Know allergy to any drug used in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Asyut, Egypt

Location

Related Publications (3)

  • SPIEGEL P. Caudal anesthesia in pediatric surgery: a preliminary report. Anesth Analg. 1962 Mar-Apr;41:218-21. No abstract available.

    PMID: 13915759BACKGROUND

  • de Beer DA, Thomas ML. Caudal additives in children--solutions or problems? Br J Anaesth. 2003 Apr;90(4):487-98. doi: 10.1093/bja/aeg064. No abstract available.

    PMID: 12644422BACKGROUND

  • Lake CL, Duckworth EN, DiFazio CA, Durbin CG, Magruder MR. Cardiovascular effects of nalbuphine in patients with coronary or valvular heart disease. Anesthesiology. 1982 Dec;57(6):498-503. doi: 10.1097/00000542-198212000-00012.

    PMID: 6983316BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Nalbuphine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 9, 2018

First Posted

March 26, 2018

Study Start

March 1, 2018

Primary Completion

March 1, 2020

Study Completion

October 1, 2020

Last Updated

March 24, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)