Trials Sponsors Conditions Drugs Pricing

Conditions

Pain, Postoperative Developmental Dysplasia of the Hip

Keywords

caudal blockdexamethasonepostoperative analgesiapediatric anesthesiaregional anesthesiabupivacaineCHEOPS

Outcome Measures

Primary Outcomes (1)

Time to first analgesic request
Time in minutes from completion of the caudal block to the first administration of a rescue analgesic, given when the CHEOPS score reached 7 or more (CHEOPS range 4-13, higher scores indicate more pain).
From caudal block to 24 hours after surgery

Secondary Outcomes (5)

Number of rescue analgesic doses
Up to 24 hours after surgery
Type of rescue analgesic
Up to 24 hours after surgery

Study Arms (2)

Dexamethasone (Group D)

EXPERIMENTAL

Intravenous dexamethasone 0.5 mg/kg (0.5 ml/kg of a 1 mg/ml solution, maximum 10 mg) at induction of anesthesia, followed by a caudal block with plain bupivacaine 0.25%, 1 ml/kg.

Drug: DexamethasoneProcedure: Caudal Block Anesthesia

Placebo (Group P)

PLACEBO COMPARATOR

Intravenous normal saline 0.5 ml/kg at induction of anesthesia, followed by a caudal block with plain bupivacaine 0.25%, 1 ml/kg.

Drug: Normal SalineProcedure: Caudal Block Anesthesia

Interventions

DexamethasoneDrug

Single intravenous dose of 0.5 mg/kg (maximum 10 mg), diluted to 1 mg/ml, given at induction of general anesthesia.

Also known as: Dexamethasone sodium phosphate

Dexamethasone (Group D)

Normal SalineDrug

Single intravenous dose of 0.5 ml/kg of 0.9% sodium chloride at induction of general anesthesia, identical in volume to the active solution.

Eligibility Criteria

Age6 Months - 9 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Children aged 6 months to 9 years
Body weight of 20 kg or less

Sponsors & Collaborators

National Institute of Neurology, Tunisia
Otherlead

Study Sites (1)

Children's Hospital of Tunis

Tunis, Tunisia

MeSH Terms

Conditions

Pain, PostoperativeDevelopmental Dysplasia of the Hip

Interventions

Dexamethasonedexamethasone 21-phosphateSaline Solution

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsHip DislocationJoint DislocationsJoint Diseases

Study Officials

Rabeb Hammami
Children's Hospital of Tunis
PRINCIPAL INVESTIGATOR

Enrollment

54 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, CARE PROVIDER
Purpose: SUPPORTIVE CARE
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Assistant Professor of Anesthesiology and Intensive Care

Study Record Dates

First Submitted

October 20, 2026

First Posted

October 26, 2026

Study Start

September 1, 2019

Actual (reported)

Intravenous Dexamethasone to Prolong Caudal Block Analgesia in Children Undergoing Hip Surgery

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Dexamethasone (Group D)

Placebo (Group P)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Dexamethasone (Group D)

Placebo (Group P)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations