Sphenopalatine Ganglion Block for Pain Relief After Pediatric Adenotonsillectomy

Summary

The aim of this clinical trial is to discover whether sphenopalatine ganglion block (SPGB) reduces postoperative pain in children aged 2 to 13 years undergoing tonsil surgery (with or without adenoid removal).

The main questions it aims to answer are:

* Does SPGB reduce postoperative pain in children undergoing throat surgery?
* Do children who receive SPGB require less pain medication after surgery?
* Do children who receive SPGB experience less nausea and vomiting after surgery?
* Do children who receive SPGB experience less bleeding during and after surgery?
* Do children who received SPGB experience fewer complications after surgery?

Researchers will perform SPGB after the child has been placed under general anesthesia, before the surgeon begins the tonsil surgery. Each child will be randomly assigned to receive the SPGB with either a local anesthetic (ropivacaine) or a placebo (saline solution, which looks the same but contains no active medication). This allows researchers to compare pain outcomes between the two groups.

To perform the SPGB, a long cotton-tipped applicator soaked in either the anesthetic or the saline solution is gently placed in each of the child's nostrils and left in place for 5-10 minutes before being removed.

Conditions

• Postoperative Pain
• Tonsillectomy
• Adenotonsillectomy

Interventions

DRUG

Sphenopalatine ganglion block (Ropivacaine)

Following induction of general anesthesia and orotracheal intubation, prior to the start of surgery, the study intervention will be performed. The patient will be in a supine position with the neck extended. Extension can be facilitated with a pillow or a folded sheet under both shoulders. A long applicator with a cotton swab at the tip is soaked with ropivacaine 1% anesthetic (maximum dose 10 mg). It is then inserted parallel to the floor of the nose until resistance is felt. The swab will be positioned at the posterior pharyngeal wall superior to the middle turbinate. The applicator will be retained in the nostril for 5-10 minutes and then removed. The procedure is repeated similarly in the other nostril. The swab does not come into direct contact with the ganglion, but the local anesthetic infiltrates the surrounding tissue. The connective tissue and mucous membrane covering the ganglion facilitate the spread and penetration of the drug.

DRUG

Sham sphenopalatine ganglion block (Saline)

Following induction of general anesthesia and orotracheal intubation, prior to the start of surgery, the study intervention will be performed. The patient will be in a supine position with the neck extended. Extension can be facilitated with a pillow or a folded sheet under both shoulders. A long applicator with a cotton swab at the tip is soaked with Saline (sham block). It is then inserted parallel to the floor of the nose until resistance is felt. The swab will be positioned at the posterior pharyngeal wall superior to the middle turbinate. The applicator will be retained in the nostril for 5-10 minutes and then removed. The procedure is repeated in the same manner in the other nostril. The swab does not come into direct contact with the ganglion, but the saline infiltrates the surrounding tissue. The connective tissue and mucous membrane covering it facilitate the spread and penetration of the saline.

Sponsors & Collaborators

• University of Sao Paulo General Hospital

  collaborator OTHER

• Vinícius C Quintão, MD, MSc, PhD

  lead OTHER

Principal Investigators

• Vinicius C Quintao, MD, MSc, PhD Investigator · Hospital das clinicas da Universidade de Sao Paulo

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

13 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-15

Primary Completion

2028-08-30

Completion

2028-12-30