Postoperative PainPhase 4SPARKNCT07793617
Sphenopalatine Ganglion Block for Pain Relief After Pediatric Adenotonsillectomy
A Phase 4 study testing Sphenopalatine ganglion block (Ropivacaine) in people with Postoperative Pain and Tonsillectomy, run by Vinícius C Quintão, MD, MSc, PhD.
Trial 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). Read more about this study
- Who is it for?
- Ages 2 to 13 years
- Conditions the study is for
- Postoperative Pain, Tonsillectomy, Adenotonsillectomy
- What is being tested?
- Sphenopalatine ganglion block (Ropivacaine)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 30 Dec 2028
- Phase
- Phase 4
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 2 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 2 to 13 years admitted for tonsillectomy/tonsillotomy with or without adenoidectomy;
- Patients classified as Physical Status I and II according to the American Society of Anesthesiologists (ASA);
- Otolaryngologists responsible for the patient according to the study and willing to report the data necessary for this study.
Who cannot join
- Children with hypersensitivity or allergy to the drugs used in the study protocol for AG and/or BGEP;
- Use of concomitant medications for anesthesia or pain control that are not in the study protocol in the pre or intraoperative period;
- Children with a history of chronic orofacial pain;
- Failure to provide written Informed Consent Form (ICF) or Informed Assent form (IAF) to participate in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Sphenopalatine Ganglion Block for Postoperative Pain Control After Adenotonsillectomy in Children
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:
Read more
- 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.
Read the detailed description
Tonsillectomy, with or without adenoidectomy, is one of the most common surgical procedures performed in children. Despite being frequent, it is associated with significant postoperative morbidity, particularly severe pain, postoperative nausea and vomiting, and bleeding. Current pain management relies heavily on opioids and nonsteroidal anti-inflammatory drugs, both of which carry risks in this population: opioids are associated with respiratory depression, of particular concern in children with obstructive sleep apnea, and increased postoperative nausea and vomiting, while NSAIDs raise concerns about postoperative bleeding.
The sphenopalatine ganglion block is a simple, minimally invasive technique that has shown promising analgesic effects in adults undergoing sinonasal and other otorhinolaryngologic surgeries, with evidence suggesting reduced postoperative pain, reduced opioid consumption, and reduced intraoperative bleeding. However, evidence supporting the safe and effective use of sphenopalatine ganglion block specifically in children undergoing adenotonsillectomy remains limited.
This study is designed to evaluate whether sphenopalatine ganglion block reduces postoperative pain compared with a sham block in children undergoing tonsillectomy or tonsillotomy, with or without adenoidectomy, for indications such as obstructive sleep apnea or recurrent tonsillitis.
Eligible participants will be randomized 1:1 using a web-based block randomization system managed by a person external to the clinical team. An unblinded team member, not otherwise involved in the child's anesthetic or surgical care, will prepare the study medication (ropivacaine or saline) according to the randomization result. All other members of the clinical and research team, as well as the participants and their families, will remain blinded to group allocation.
Based on an alpha of 0.05, a statistical power of 95%, and a medium effect size (Cramer's V = 0.3 for the chi-square test; d = 0.6 for the Mann-Whitney test), a total sample size of 145 participants was determined to provide adequate power for both the primary and key secondary outcomes.
This is the first randomized clinical trial to evaluate the effect of sphenopalatine ganglion block specifically on postoperative pain control after adenotonsillectomy in children, and its findings are intended to help inform evidence-based perioperative pain management guidelines for this common pediatric surgical population.
- Conditions
- Postoperative Pain, Tonsillectomy, Adenotonsillectomy
- Being tested
- Sphenopalatine ganglion block (Ropivacaine), Sham sphenopalatine ganglion block (Saline)
- Keywords
- sphenopalatine ganglion block, Pediatric anesthesia, Postoperative pain management, Regional anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sphenopalatine ganglion block (Ropivacaine)Drug
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.
Sham sphenopalatine ganglion block (Saline)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative sphenopalatine ganglion block with Ropivacaine | Experimental | Intraoperative sphenopalatine ganglion block performed after anesthetic induction and orotracheal intubation, before the start of surgery, with a swab and 1% ropivacaine, maximum 10 mg. Receives: Drug: Sphenopalatine ganglion block (Ropivacaine) |
| Sham intraoperative sphenopalatine ganglion block with saline | Sham comparator | Sham intraoperative sphenopalatine ganglion block performed after anesthetic induction and orotracheal intubation, before the start of surgery, with a swab and saline. Receives: Drug: Sham sphenopalatine ganglion block (Saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative pain in the Post-Anesthesia Care Unit (PACU) after adenotonsillectomy
Comparison of the incidence of immediate postoperative pain in the PACU between children who received sphenopalatine ganglion block (SPGB) with ropivacaine 1% and children who received sham block (0.9% NaCl). Pain will be measured using the highest pain score recorded in the PACU, using an age-appropriate scale:
- < 4 years: Revised FLACC Scale
- > 4 and < 6 years: Revised FACES Scale
- ≥ 6 years: Numeric Rating Scale (NRS)
A score ≥ 4 on any of these scales will be considered as presence of pain. The analysis will compare the proportion of patients with pain (score ≥4) between the two groups, with estimation of the risk difference and 95% confidence interval.
Measured: From admission to the PACU until PACU discharge, assessed at admission and every 20 minutes, up to an estimated 60 minutes
Secondary outcomes (13)
Use of rescue opioids and/or analgesics in the PACU (Post-Anesthesia Care Unit)
Use of rescue opioids and/or analgesics in the PACU (Post-Anesthesia Care Unit): yes or no.
Measured: From admission to the PACU until PACU discharge, up to an estimated 60 minutes
Use of rescue opioids and/or analgesics at the time of hospital discharge
Use of rescue opioids and/or analgesics at the time of hospital discharge: yes or no.
Measured: At hospital discharge, assessed up to an estimated 24 hours after surgery
Postoperative pain at the time of hospital discharge
Postoperative pain at the time of hospital discharge: yes or no.
Measured: At hospital discharge, assessed up to an estimated 24 hours after surgery
Nausea and vomiting in the PACU
Nausea and vomiting in the PACU? yes or no.
Measured: From admission to the PACU until PACU discharge, up to an estimated 60 minutes
Nausea and vomiting at the time of hospital discharge
Nausea and vomiting at the time of hospital discharge: yes or no.
Measured: At hospital discharge, assessed up to an estimated 24 hours after surgery
Consumption of rescue antiemetics in the PACU
Consumption of rescue antiemetics in the PACU: yes or no.
Measured: From admission to the PACU until PACU discharge, up to an estimated 60 minutes
Consumption of rescue antiemetics at the time of hospital discharge
Consumption of rescue antiemetics at the time of hospital discharge: yes or no.
Measured: At hospital discharge, assessed up to an estimated 24 hours after surgery
Intraoperative bleeding
Surgeon's opinion on perioperative bleeding: very reduced, reduced, usual, increased, or very increased.
Measured: Assessed intraoperatively, at the end of the surgical procedure
Postoperative bleeding
Postoperative bleeding: yes or no The surgeon will inform you if bleeding resulting from the surgical procedure occurs up to 30 days after the surgery.
Measured: From the end of surgery up to 30 days after surgery
Surgical reintervention
Surgical reintervention: yes or no Need for surgical re-intervention.
Measured: From the end of surgery up to 30 days after surgery
Medical consultations outside the scheduled
Medical consultations outside the scheduled postoperative control due to complications within the first 30 days of surgery:
- Consultations only.
- Readmission for observation. 12. Critical perioperative respiratory events: laryngospasm, stridor, bronchial aspiration, hypoxia (O2 saturation < 90% for 2 minutes), use of supplemental oxygen in the PACU.
Measured: From the end of surgery up to 30 days after surgery
Morbidity in the first 30 days after surgery
Morbidity in the first 30 days after surgery: admission to intensive care unit or ICU, readmission due to: NGO infection, dehydration, pulmonary infection, pulmonary complications, seizure.
Measured: From the end of surgery up to 30 days after surgery
Mortality in the first 30 days after surgery
Mortality: yes or no
Measured: From the end of surgery up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start15 Sep 2026 (estimated)
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 into two parallel groups: the intervention group (sphenopalatine ganglion block with ropivacaine 1%) and the control group (sham block with 0.9% NaCl).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vinícius C Quintão, MD, MSc, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo General Hospital
- Responsible party
- Sponsor-investigator, Vinícius C Quintão, MD, MSc, PhD, University of Sao Paulo General Hospital
- Investigators
- Vinicius C Quintao, MD, MSc, PhD Investigator, Principal investigator, Hospital das clinicas da Universidade de Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793617
- Sponsor's protocol ID
- SPARK
- Acronym
- SPARK
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Myles Hollander and Douglas A. Wolfe (1973). Nonparametric Statistical Methods. New York: John Wiley & Sons. Pages 68-75
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343Lin C, Abboud S, Zoghbi V, Kasimova K, Thein J, Meister KD, Sidell DR, Balakrishnan K, Tsui BCH. Suprazygomatic Maxillary Nerve Blocks and Opioid Requirements in Pediatric Adenotonsillectomy: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2024 Jul 1;150(7):564-571. doi: 10.1001/jamaoto.2024.1011.
PubMed 38780948Albazee E, AlRajhi B, Alfadhli A, Alharran AM, Al-Qudah M. Sphenopalatine ganglion block for pain control after septoplasty: a systematic review and meta-analysis with trial sequential analysis. Rhinology. 2024 Dec 1;62(6):642-651. doi: 10.4193/Rhin24.225.
PubMed 39323198Horiguchi CLF, Horiguchi CHV, Bittencourt LG et al. Complicações possivelmente relacionadas ao bloqueio do gânglio esfenopalatino para tratamento de cefaleia pós-punção dural: série de casos. Revista Medica de Minas Gerais 2019;29 (supl 11): S12-S15 Volume: 29. (Suppl.11).
Nair AS, Rayani BK. Sphenopalatine ganglion block for relieving postdural puncture headache: technique and mechanism of action of block with a narrative review of efficacy. Korean J Pain. 2017 Apr;30(2):93-97. doi: 10.3344/kjp.2017.30.2.93. Epub 2017 Mar 31.
PubMed 28416992Windsor RE, Jahnke S. Sphenopalatine ganglion blockade: a review and proposed modification of the transnasal technique. Pain Physician. 2004 Apr;7(2):283-6.
PubMed 16868606Lauder G, Emmott A. Confronting the challenges of effective pain management in children following tonsillectomy. Int J Pediatr Otorhinolaryngol. 2014 Nov;78(11):1813-27. doi: 10.1016/j.ijporl.2014.08.011. Epub 2014 Aug 27.
PubMed 25241379Riggin L, Ramakrishna J, Sommer DD, Koren G. A 2013 updated systematic review & meta-analysis of 36 randomized controlled trials; no apparent effects of non steroidal anti-inflammatory agents on the risk of bleeding after tonsillectomy. Clin Otolaryngol. 2013 Apr;38(2):115-29. doi: 10.1111/coa.12106.
PubMed 23448586Kelly LE, Sommer DD, Ramakrishna J, Hoffbauer S, Arbab-Tafti S, Reid D, Maclean J, Koren G. Morphine or Ibuprofen for post-tonsillectomy analgesia: a randomized trial. Pediatrics. 2015 Feb;135(2):307-13. doi: 10.1542/peds.2014-1906.
PubMed 25624387Tan GX, Tunkel DE. Control of Pain After Tonsillectomy in Children: A Review. JAMA Otolaryngol Head Neck Surg. 2017 Sep 1;143(9):937-942. doi: 10.1001/jamaoto.2017.0845.
PubMed 28662233Windfuhr JP, Chen YS, Remmert S. Hemorrhage following tonsillectomy and adenoidectomy in 15,218 patients. Otolaryngol Head Neck Surg. 2005 Feb;132(2):281-6. doi: 10.1016/j.otohns.2004.09.007.
PubMed 15692542Bolton CM, Myles PS, Nolan T, Sterne JA. Prophylaxis of postoperative vomiting in children undergoing tonsillectomy: a systematic review and meta-analysis. Br J Anaesth. 2006 Nov;97(5):593-604. doi: 10.1093/bja/ael256. Epub 2006 Sep 26.
PubMed 17005507Stanko D, Bergesio R, Davies K, Hegarty M, von Ungern-Sternberg BS. Postoperative pain, nausea and vomiting following adeno-tonsillectomy - a long-term follow-up. Paediatr Anaesth. 2013 Aug;23(8):690-6. doi: 10.1111/pan.12170. Epub 2013 May 13.
PubMed 23668258Stewart DW, Ragg PG, Sheppard S, Chalkiadis GA. The severity and duration of postoperative pain and analgesia requirements in children after tonsillectomy, orchidopexy, or inguinal hernia repair. Paediatr Anaesth. 2012 Feb;22(2):136-43. doi: 10.1111/j.1460-9592.2011.03713.x. Epub 2011 Oct 25.
PubMed 22023485