Fentanyl Versus Opioid Free Multimodal Analgesia for Perioperative Pain Control in Children With Mild to Moderate Obstructive Sleep Apnea
Key facts
- Who runs it
- Ain Shams University
- Where
- Egypt1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Not yet recruiting
- People taking part
- 64 people, planned
- Starts
- 30 Nov 2026
- Expected to end
- 30 Dec 2026
- Type of study
- Interventional, 2 groups
- Treatments tested
- Group A: Fentanyl-Based Analgesia
- Group B: Opioid-Free Multimodal Analgesia
- Record updated
- 27 February 2026
Who can take part
- Age
- 5 years to 10 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- Children aged 5-10 years
- Diagnosed with mild to moderate Obstructive Sleep Apnea (apnea-hypoxia index 1-10)
- Scheduled for elective adenotonsillectomy
- American Society of Anesthesiologists physical status I-II
Who cannot take part
- Known allergies to study medications
- History of opioid use or chronic pain syndromes
- Neurological or metabolic disorders affecting pain perception
- Severe Obstructive Sleep Apnea (apnea-hypoxia index >10)
- Patient with predicted difficult air way (Mallampatti 3\&4)
- Parental refusal to consent
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 5 and 10 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Emphasize that the usage of multimodal analgesia in managing perioperative pain in children with mild to moderate Obstructive Sleep Apnea undergoing adenotonsillectomy may achieve the same efficacy of fentanyl with less respiratory complications and less opioid-related side effects.
The 2 groups in the trial
- Fentanyl-Based Analgesia groupTreatment being tested
Fentanyl-Based Analgesia will receive intraoperative fentanyl (1 μg/kg IV) with standard anesthetic care with postoperative rescue analgesia with acetaminophen (15 mg/kg) as needed.
Treatment: Group A: Fentanyl-Based Analgesia
- Opioid-Free Multimodal Analgesia groupTreatment being tested
Opioid-Free Multimodal Analgesia will receive preoperative acetaminophen (15 mg/kg) and ibuprofen (10 mg/kg), intraoperative ketamine (0.5 mg/kg IV) and dexamethasone (0.1 mg/kg IV) with postoperative rescue analgesia with acetaminophen as needed.
Treatment: Group B: Opioid-Free Multimodal Analgesia
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT07435493, who can take part
- Record updated
- 27 February 2026