A Phase 4 interventional study of Dexamethasone and Normal Saline in Pain, Postoperative and Developmental Dysplasia of the Hip, sponsored by National Institute of Neurology, Tunisia. Completed at 1 site in Tunisia. Open to participants aged 6 Months to 9 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by National Institute of Neurology, Tunisia · Phase 4, Interventional, and Supportive care
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.
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.
5,265 studies on the registry are indexed under Pain, Postoperative; 1,165 are open to participants now.
This study's enrollment of 54 is below the median of 75 across 4,496 interventional studies indexed under Pain, Postoperative.
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Exclusion Criteria:
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: Dexamethasone · Procedure: Caudal Block Anesthesia
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 Saline · Procedure: Caudal Block Anesthesia
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
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.
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.
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).
Time frame: From caudal block to 24 hours after surgery
Number of rescue analgesic doses
Total number of paracetamol and nalbuphine doses administered per child.
Time frame: Up to 24 hours after surgery
Type of rescue analgesic
Proportion of children receiving paracetamol alone, or paracetamol and nalbuphine.
Time frame: Up to 24 hours after surgery
Postoperative pain score
CHEOPS score (range 4-13, higher scores indicate more pain).
Time frame: 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.
Time frame: Up to 24 hours after surgery
Perioperative adverse events
Number of children with anesthetic or surgical adverse events.
Time frame: From induction to 24 hours after surgery
Plan to share: No — Individual participant data will not be shared. Aggregate results will be published in a peer-reviewed journal.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Dexamethasone
National Institute of Neurology, Tunisia