Fentanyl Versus Opioid Free Multimodal Analgesia for Perioperative Pain Control in Children With Mild to Moderate Obstructive Sleep Apnea

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-10
SponsorAin Shams University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Group A: Fentanyl-Based Analgesia

    Drug

    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 Analgesia

    Drug

    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 groups

64 Participants
are divided into 2 treatment groups
Group A: Fentanyl-Based Analgesia groupExperimental treatment 1 intervention
Group B: Opioid-Free Multimodal Analgesia groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
at 0 hours, 2hours, and 6 hours postoperatively

Secondary outcomes

1

Time to oral intake

Time frame
6 hours postoperatively

Other outcomes

Sponsors and contacts

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