Pain, PostoperativePhase 4DEXA-CAUDALNCT07896304
Intravenous Dexamethasone to Prolong Caudal Block Analgesia in Children Undergoing Hip Surgery
A Phase 4 study testing Dexamethasone, Normal Saline and Caudal Block Anesthesia in people with Pain, Postoperative and Developmental Dysplasia of the Hip, run by National Institute of Neurology, Tunisia at 1 site in Tunisia.
Trial summary
The goal of this clinical trial is to learn whether a single intravenous dose of dexamethasone prolongs postoperative analgesia after a caudal block in children aged 6 months to 9 years undergoing surgery for developmental dysplasia of the hip. Read more about this study
- Who is it for?
- Ages 6 months to 9 years
- Conditions the study is for
- Pain, Postoperative, Developmental Dysplasia of the Hip
- What is being tested?
- Dexamethasone, Normal Saline and Caudal Block Anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Sep 2019to 1 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6 months to 9 years
- Body weight of 20 kg or less
- ASA physical status I or II
- Scheduled for surgery for unilateral or bilateral developmental dysplasia of the hip
- Eligible for caudal analgesia
- Written informed consent from a parent
Who cannot join
- Parental refusal
- Contraindication to inhalational induction with sevoflurane
- Contraindication to caudal block
- Coagulation disorder or anticoagulant treatment
- Allergy to local anesthetics
- Intellectual disability
- Corticosteroid treatment in the days before surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intravenous Dexamethasone on the Duration of Caudal Block Analgesia in Children Undergoing Surgery for Developmental Dysplasia of the Hip: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial
The goal of this clinical trial is to learn whether a single intravenous dose of dexamethasone prolongs postoperative analgesia after a caudal block in children aged 6 months to 9 years undergoing surgery for developmental dysplasia of the hip. The main question it aims to answer is: does intravenous dexamethasone (0.5 mg/kg) lengthen the time to first rescue analgesic compared with placebo? Researchers compared dexamethasone with normal saline (placebo). All children received general anesthesia and a caudal block with bupivacaine 0.25%, and pain was assessed with the CHEOPS score during the first 24 postoperative hours.
Read the detailed description
This prospective, randomized, double-blind, placebo-controlled trial was conducted in the Department of Anesthesiology and Intensive Care of the Children's Hospital Bechir Hamza of Tunis between September 2019 and December 2020, after approval by the local ethics committee and written informed consent from a parent.
Children aged 6 months to 9 years, weighing 20 kg or less, ASA physical status I or II, scheduled for unilateral or bilateral surgery for developmental dysplasia of the hip, were eligible.
Anesthesia was induced by inhalation of sevoflurane 8% in a 50% nitrous oxide/oxygen mixture, followed by propofol 2 mg/kg and fentanyl 3 µg/kg after peripheral venous access. The trachea was intubated, ventilation was controlled (tidal volume 7 ml/kg, end-tidal CO2 target 35 mmHg) and anesthesia was maintained with sevoflurane at 1 MAC.
At induction, children were randomized with the Random Allocation software to receive either dexamethasone 0.5 mg/kg (0.5 ml/kg of a 1 mg/ml solution, maximum 10 mg) intravenously (Group D) or the same volume of normal saline (Group P). The physician administering the study solution, the child and the parents were blinded to group allocation.
A single-shot caudal block was then performed in the lateral position with a 22 G, 30 mm short-bevel caudal needle, injecting 1 ml/kg of plain bupivacaine 0.25% after negative aspiration. Surgical incision took place at least 10 minutes after the block. Block failure was defined as an increase of more than 20% in heart rate and/or blood pressure from baseline within 20 minutes of incision; these children received fentanyl 2 µg/kg and were excluded.
No analgesic was given routinely after surgery. Pain was assessed with the CHEOPS score at awakening, 30 minutes and 1, 2, 3, 4, 8, 12 and 24 hours after surgery. A CHEOPS score of 7 or more triggered intravenous paracetamol 15 mg/kg; if the score remained above 7 after 30 minutes, nalbuphine 0.2 mg/kg was infused over 20 minutes.
The primary outcome was the time to first analgesic request, from caudal block to first analgesic administration. Secondary outcomes were the number and type of analgesics given, the incidence of postoperative nausea and vomiting, and perioperative anesthetic or surgical adverse events.
Sample size: based on a previous trial in children undergoing orchidopexy (time to first analgesic 8.33 ± 0.98 h with dexamethasone versus 6.00 ± 1.15 h with placebo), 26 children per group were required (two-sided alpha 5%, beta 5%). Data were analyzed with IBM SPSS 23 using Pearson's chi-square test, Student's t-test or the Mann-Whitney test as appropriate, and Kaplan-Meier survival analysis for the primary outcome. A p-value below 0.05 was considered significant.
- Being tested
- Dexamethasone, Normal Saline, Caudal Block Anesthesia
- Keywords
- caudal block, dexamethasone, postoperative analgesia, pediatric anesthesia, regional anesthesia, bupivacaine, CHEOPS
- Medical subject headings
- Pain, Postoperative, Developmental Dysplasia of the Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Dexamethasone sodium phosphate
Single intravenous dose of 0.5 mg/kg (maximum 10 mg), diluted to 1 mg/ml, given at induction of general anesthesia.
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.
Caudal Block AnesthesiaProcedure or surgery
Single-shot caudal epidural block with plain bupivacaine 0.25%, 1 ml/kg, performed after induction with a 22 G short-bevel caudal needle, at least 10 minutes before incision.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Dexamethasone; Procedure: 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. Receives: Drug: Normal Saline; Procedure: Caudal Block Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From caudal block to 24 hours after surgery
Secondary outcomes (5)
Number of rescue analgesic doses
Total number of paracetamol and nalbuphine doses administered per child.
Measured: Up to 24 hours after surgery
Type of rescue analgesic
Proportion of children receiving paracetamol alone, or paracetamol and nalbuphine.
Measured: Up to 24 hours after surgery
Postoperative pain score
CHEOPS score (range 4-13, higher scores indicate more pain).
Measured: At awakening, 30 minutes, 1, 2, 3, 4, 8, 12 and 24 hours after surgery
Incidence of postoperative nausea and vomiting
Proportion of children with at least one episode of nausea or vomiting.
Measured: Up to 24 hours after surgery
Perioperative adverse events
Number of children with anesthetic or surgical adverse events.
Measured: From induction to 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start1 Sep 2019
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurology, Tunisia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hammami Rabeb, Children's Hospital of Tunis
- Investigators
- Rabeb Hammami, Principal investigator, Children's Hospital of Tunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896304
- Sponsor's protocol ID
- HEBH-ANESTH-2026-01
- Acronym
- DEXA-CAUDAL
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Aggregate results will be published in a peer-reviewed journal.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Dexamethasone on the Duration of Caudal Block Analgesia in Children Undergoing Surgery for Developmental Dysplasia of the Hip: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07896304
- Acronym / sponsor ID
- DEXA-CAUDAL / HEBH-ANESTH-2026-01
- Keywords
- caudal block, dexamethasone, postoperative analgesia, pediatric anesthesia, regional anesthesia, bupivacaine, CHEOPS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- National Institute of Neurology, TunisiaUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn whether a single intravenous dose of dexamethasone prolongs postoperative analgesia after a caudal block in children aged 6 months to 9 years undergoing surgery for developmental dysplasia of the hip. The main question it aims to answer is: does intravenous dexamethasone (0.5 mg/kg) lengthen the time to first rescue analgesic compared with placebo? Researchers compared dexamethasone with normal saline (placebo). All children received general anesthesia and a caudal block with bupivacaine 0.25%, and pain was assessed with the CHEOPS score during the first 24 postoperative hours.
Detailed description
This prospective, randomized, double-blind, placebo-controlled trial was conducted in the Department of Anesthesiology and Intensive Care of the Children's Hospital Bechir Hamza of Tunis between September 2019 and December 2020, after approval by the local ethics committee and written informed consent from a parent.
Children aged 6 months to 9 years, weighing 20 kg or less, ASA physical status I or II, scheduled for unilateral or bilateral surgery for developmental dysplasia of the hip, were eligible.
Anesthesia was induced by inhalation of sevoflurane 8% in a 50% nitrous oxide/oxygen mixture, followed by propofol 2 mg/kg and fentanyl 3 µg/kg after peripheral venous access. The trachea was intubated, ventilation was controlled (tidal volume 7 ml/kg, end-tidal CO2 target 35 mmHg) and anesthesia was maintained with sevoflurane at 1 MAC.
At induction, children were randomized with the Random Allocation software to receive either dexamethasone 0.5 mg/kg (0.5 ml/kg of a 1 mg/ml solution, maximum 10 mg) intravenously (Group D) or the same volume of normal saline (Group P). The physician administering the study solution, the child and the parents were blinded to group allocation.
A single-shot caudal block was then performed in the lateral position with a 22 G, 30 mm short-bevel caudal needle, injecting 1 ml/kg of plain bupivacaine 0.25% after negative aspiration. Surgical incision took place at least 10 minutes after the block. Block failure was defined as an increase of more than 20% in heart rate and/or blood pressure from baseline within 20 minutes of incision; these children received fentanyl 2 µg/kg and were excluded.
No analgesic was given routinely after surgery. Pain was assessed with the CHEOPS score at awakening, 30 minutes and 1, 2, 3, 4, 8, 12 and 24 hours after surgery. A CHEOPS score of 7 or more triggered intravenous paracetamol 15 mg/kg; if the score remained above 7 after 30 minutes, nalbuphine 0.2 mg/kg was infused over 20 minutes.
The primary outcome was the time to first analgesic request, from caudal block to first analgesic administration. Secondary outcomes were the number and type of analgesics given, the incidence of postoperative nausea and vomiting, and perioperative anesthetic or surgical adverse events.
Sample size: based on a previous trial in children undergoing orchidopexy (time to first analgesic 8.33 ± 0.98 h with dexamethasone versus 6.00 ± 1.15 h with placebo), 26 children per group were required (two-sided alpha 5%, beta 5%). Data were analyzed with IBM SPSS 23 using Pearson's chi-square test, Student's t-test or the Mann-Whitney test as appropriate, and Kaplan-Meier survival analysis for the primary outcome. A p-value below 0.05 was considered significant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone (Group D) | Experimental | Drug: Dexamethasone, Procedure: Caudal Block AnesthesiaIntravenous 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. |
| Placebo (Group P) | Placebo comparator | Drug: Normal Saline, Procedure: Caudal Block AnesthesiaIntravenous normal saline 0.5 ml/kg at induction of anesthesia, followed by a caudal block with plain bupivacaine 0.25%, 1 ml/kg. |
Who may qualify
- Ages
- 6 months to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 6 months to 9 years
- Body weight of 20 kg or less
- ASA physical status I or II
- Scheduled for surgery for unilateral or bilateral developmental dysplasia of the hip
- Eligible for caudal analgesia
Key exclusion criteria (7 listed)
- Parental refusal
- Contraindication to inhalational induction with sevoflurane
- Contraindication to caudal block
- Coagulation disorder or anticoagulant treatment
- Allergy to local anesthetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: Dexamethasone sodium phosphateSingle intravenous dose of 0.5 mg/kg (maximum 10 mg), diluted to 1 mg/ml, given at induction of general anesthesia. | Drug | Dexamethasone (Group D) |
| Normal SalineSingle intravenous dose of 0.5 ml/kg of 0.9% sodium chloride at induction of general anesthesia, identical in volume to the active solution. | Drug | Placebo (Group P) |
| Caudal Block AnesthesiaSingle-shot caudal epidural block with plain bupivacaine 0.25%, 1 ml/kg, performed after induction with a 22 G short-bevel caudal needle, at least 10 minutes before incision. | Procedure or surgery | Dexamethasone (Group D), Placebo (Group P) |
Primary outcome
Time to first analgesic request
Time frame: From caudal block to 24 hours after surgery
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).
5 secondary outcomes
Number of rescue analgesic doses
Time frame: Up to 24 hours after surgery
Type of rescue analgesic
Time frame: Up to 24 hours after surgery
Postoperative pain score
Time frame: At awakening, 30 minutes, 1, 2, 3, 4, 8, 12 and 24 hours after surgery
Incidence of postoperative nausea and vomiting
Time frame: Up to 24 hours after surgery
Perioperative adverse events
Time frame: From induction to 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Aggregate results will be published in a peer-reviewed journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rabeb Hammami principal investigator
Children's Hospital of Tunis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone, Normal Saline and Caudal Block Anesthesia in people with Pain, Postoperative and Developmental Dysplasia of the Hip, run by National Institute of Neurology, Tunisia at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first analgesic request (time frame: From caudal block to 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.