NCT03714919

A Pilot Study: a Non-opioid Technique for Postoperative Adenoidectomy Pain Relief in Pediatric Patients

Completed Phase 2 Results posted Last updated 5 February 2021

What this trial tests

Phase 2 trial testing Dextromethorphan in Adenoid Hypertrophy in 10 participants. Completed in 10 November 2019.

Timeline

2 August 2019

Primary endpoint
10 November 2019

10 November 2019

Quick facts

Lead sponsor	Arlyne Thung
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	2 August 2019
Primary completion	10 November 2019
Estimated completion	10 November 2019
Sites	1 location across United States

Drugs / interventions tested

• Dextromethorphan — full drug profile →
• Acetaminophen (Paracetamol) — full drug profile →
• Dexmedetomidine (dexmedetomidine) — full drug profile →
• Ketamine (ketamine) — full drug profile →

Conditions studied

• Adenoid Hypertrophy — all drugs for Adenoid Hypertrophy →

Sponsor

Arlyne Thung

Who can join

Adults 4 to 8, any sex, with Adenoid Hypertrophy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Average Pain Score Primary · 1 hr post-op

Visual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) in post-anesthesia care unit (PACU).

Group	Value	95% CI
Non-opiod Pain Relief	0	± 0

Extubation Time Secondary · 1 hr post-op

Amount of time in the PACU before patient is ready to be extubated.

Group	Value	95% CI
Non-opiod Pain Relief	23	17 – 29

Time in PACU Secondary · 1-2 hr post-op

Total time in PACU before patient met discharge criteria.

Group	Value	95% CI
Non-opiod Pain Relief	56	49 – 65

Number of Participants With Sedation, Nausea/Vomiting, or Hallucinations Secondary · 2 hours post-op

Presence of sedation, nausea/vomiting, or hallucinations post-operatively.

Sedation

Group	Value	95% CI
Non-opiod Pain Relief	7

Nausea/Vomiting

Group	Value	95% CI
Non-opiod Pain Relief	1

Hallucinations

Group	Value	95% CI
Non-opiod Pain Relief	0

End of Surgery to Hospital Discharge Secondary · 2-3 hours post-op

Length of time before patient is ready to be discharged home.

Group	Value	95% CI
Non-opiod Pain Relief	122	106 – 187

Sponsor's own description

This proposed study will assess analgesic efficacy of a multi-modal, non-opioid analgesic regimen for providing surgical analgesia in pediatric patients undergoing adenoidectomy and to assess recovery characteristics in the post-anesthesia care unit (PACU) and at home following surgery.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Opioid-Sparing Anesthetic Technique for Pediatric Patients Undergoing Adenoidectomy: A Pilot Study.
   Alghamdi F, Roth C, Jatana KR, Elmaraghy CA, et al · · 2020 · cited 8× · PMID 33239908 · DOI 10.2147/jpr.s281275