AdenotonsillectomyNCT07435493
Fentanyl Versus Opioid Free Multimodal Analgesia for Perioperative Pain Control in Children With Mild to Moderate Obstructive Sleep Apnea
A study testing Group A: Fentanyl-Based Analgesia and Group B: Opioid-Free Multimodal Analgesia in people with Adenotonsillectomy and Obstructive Sleep Apnea (OSA), run by Ain Shams University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Adenotonsillectomy, Obstructive Sleep Apnea (OSA), Fentanyl
- What is being tested?
- Group A: Fentanyl-Based Analgesia and Group B: Opioid-Free Multimodal Analgesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Nov 2026to 30 Dec 2026
- Phase
- Interventional
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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 join
- Severe Obstructive Sleep Apnea (apnea-hypoxia index >10).
- Known allergies to study medications.
- Patient with predicted difficult air way (Mallampatti 3\&4).
- History of opioid use or chronic pain syndromes.
- Neurological or metabolic disorders affecting pain perception.
- Parental refusal to consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Ain shams university
Cairo
Anhar Falila, Assistant lecturer, 01222176925, Anhar.fathy@med.asu.edu.eg
About this study
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.
Read the detailed description
Obstructive Sleep Apnea in pediatrics is a sleep disorder characterized by repeated episodes of partial or complete upper airway obstruction during sleep, leading to disrupted breathing, poor sleep quality, and potential developmental and health issues.
Since adeno-tonsillar hypertrophy and enlarged tonsils \& adenoids are the most common causes of pediatric Obstructive Sleep Apnea ,thus adenotonsillectomy is the first-line surgical treatment and is one of the most common pediatric surgeries that has a high success rate in resolving Obstructive Sleep Apnea symptoms with cure rate up to 80%.
Adenotonsillectomy is a common surgical procedure in pediatric patients and perioperative pain management with opioids is common and associated with side effects and risks. Consequently, analgesic strategies to reduce opioid utilization have been developed, because Obstructive Sleep Apnea patients are more sensitive to opioids.
Fentanyl has demonstrated efficacy in pediatrics for acute pain management but still has the risk of opioids induced ventilatory impairment which is very common in children with obstructive sleep apnea due to altered volume of distribution and clearance.
A multimodal analgesia approach, which combines various non-opioid medications (acetaminophen, non-steroidal anti-inflammatory drugs, dexamethasone and ketamine ) can effectively manage perioperative pain in children with mild to moderate Obstructive Sleep Apnea with (apnea hypoxia index <or= 10) undergoing adenotonsillectomy, while minimizing the risks associated with opioid use.
The purpose of this study is to emphasize that the usage of multimodal analgesia in managing perioperative pain in children with mild to moderate OSA undergoing adenotonsillectomy may achieve the same efficacy of fentanyl with less respiratory complications and less opioid-related side effects.
- Conditions
- Adenotonsillectomy, Obstructive Sleep Apnea (OSA), Fentanyl, Opioid
- Being tested
- Group A: Fentanyl-Based Analgesia, Group B: Opioid-Free Multimodal Analgesia
- Keywords
- opioid, Fentanyl, obstructive sleep apnea, adenotonsillectomy
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A: Fentanyl-Based AnalgesiaDrug
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
Group B: Opioid-Free Multimodal AnalgesiaDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl-Based Analgesia group | Experimental | 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. Receives: Drug: Group A: Fentanyl-Based Analgesia |
| Opioid-Free Multimodal Analgesia group | Experimental | 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. Receives: Drug: Group B: Opioid-Free Multimodal Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
FLACC Scale (face, legs, activity, cry, consolability)
It grades pain from 0 to 10 by observing five categories-Face, Legs, Activity, Cry, and Consolability-with each item scored 0-2.
Measured: at 0 hours, 2hours, and 6 hours postoperatively
Secondary outcomes (1)
Time to oral intake
Measured: 6 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start30 Nov 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenotonsillectomyStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anhar Fathy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435493
- Sponsor's protocol ID
- FMASU MD141/2025
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data ill be available when it needed