Postoperative PainNCT07915804
Perfusion Index for Postoperative Pain Assessment in Pediatric Adenotonsillectomy
A study testing Bilateral Intraoral Glossopharyngeal Nerve Block in people with Postoperative Pain and Adenotonsillectomy, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate the usefulness of the perfusion index (PI) as an objective measure of postoperative pain in children aged 1-12 years undergoing adenotonsillectomy. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Postoperative Pain, Adenotonsillectomy, Pain
- What is being tested?
- Bilateral Intraoral Glossopharyngeal Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Oct 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients aged 1-12 years
- Scheduled to undergo elective adenotonsillectomy
- American Society of Anesthesiologists (ASA) physical status I-II
- Written informed consent obtained from a parent or legal guardian
Who cannot join
- American Society of Anesthesiologists (ASA) physical status III or higher
- Perioperative hemodynamic instability
- Perioperative respiratory instability
- Known allergy to local anesthetic agents
- Chronic pain or neurological disease
- Peripheral circulatory disorders that may affect perfusion index measurements
- Anticipated need for postoperative intensive care
- Absence of written informed consent from a parent or legal guardian
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University, Istanbul Faculty of Medicine, Department of Anesthesiology and Reanimation
Istanbul, Istanbul
Salih A AKINCI, Research Assistant, +905524338021, salih.akinci@istanbul.edu.tr
About this study
Official title: Evaluation of Postoperative Pain With Perfusion Index Measurement in Pediatric Adenotonsillectomy: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the usefulness of the perfusion index (PI) as an objective measure of postoperative pain in children aged 1-12 years undergoing adenotonsillectomy. Participants will be randomized into two groups: a control group receiving standard general anesthesia and multimodal analgesia, and an intervention group receiving an additional bilateral glossopharyngeal nerve block with 0.25% bupivacaine. Postoperative PI measurements will be compared with validated pediatric pain scales, including the Face, Legs, Activity, Cry, Consolability (FLACC) and Wong-Baker FACES scales.
Read the detailed description
This single-center, prospective, randomized controlled study will include 50 pediatric patients aged 1-12 years with American Society of Anesthesiologists (ASA) physical status I-II scheduled for elective adenotonsillectomy. Participants will be randomized in a 1:1 ratio using sealed envelopes into a control group and a glossopharyngeal nerve block group.
All patients will receive A standardized anesthetic protocol will be applied to all participants. Inhalational induction of anesthesia will be initiated with sevoflurane using a fresh gas flow of 12 L/min and an inspired oxygen concentration of approximately 92%, with sevoflurane at 8%. After intravenous access is established, fentanyl 2 µg/kg and rocuronium 0.4 mg/kg will be administered to facilitate tracheal intubation.
The operating room temperature will be maintained between 20°C and 23°C throughout the procedure in order to minimize the potential influence of ambient temperature on peripheral perfusion. All patients will also receive active forced-air warming intraoperatively.
As part of the standardized perioperative management, all participants will receive ampicillin-sulbactam 25 mg/kg for surgical antimicrobial prophylaxis, dexamethasone 0.1 mg/kg, methylprednisolone 1 mg/kg, and paracetamol 15 mg/kg.
In the intervention group, a bilateral intraoral glossopharyngeal nerve block will be performed after induction of general anesthesia using 0.25% bupivacaine at a total dose of 0.2 mL/kg, divided equally between both sides, following negative aspiration and injection into the anterior or posterior tonsillar pillars.
Baseline PI measurements will be obtained preoperatively from the right index finger. Additional PI measurements will be obtained 20 minutes after tracheal intubation and during the postoperative recovery period. PI will also be assessed upon admission to and before discharge from the post-anesthesia care unit (PACU). At each measurement point, three consecutive readings will be recorded and their mean value will be used for statistical analysis.
Postoperative pain will be assessed using the FLACC scale in 1-3 years children and the Wong-Baker FACES Pain Rating Scale in 4-12 children. In both rating scales patients with a pain score of 6 or greater will receive intravenous ibuprofen at a dose of 10 mg/kg. Pain assessments will be performed during the postoperative recovery period, including after approximately 30 minutes of observation in the PACU. Vital signs, postoperative nausea and vomiting (PONV), rescue analgesic requirements, and other postoperative complications will also be recorded.
- Conditions
- Postoperative Pain, Adenotonsillectomy, Pain, Pediatric
- Being tested
- Bilateral Intraoral Glossopharyngeal Nerve Block
- Keywords
- perfusion index, glossopharyngeal nerve block, FLACC, Wong-Baker FACES, objective pain assessment
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Intraoral Glossopharyngeal Nerve BlockProcedure or surgery
After induction of general anesthesia, a bilateral intraoral glossopharyngeal nerve block will be performed using 0.25% bupivacaine at a total volume of 0.2 mL/kg, divided equally between both sides. Following negative aspiration, the local anesthetic will be injected into the anterior or posterior tonsillar pillars bilaterally.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Control) | No intervention | standard general anesthesia and multimodal analgesia, no nerve block |
| Group 2 (Glossopharyngeal Nerve Block) | Experimental | Participants in this group will receive standardized general anesthesia and multimodal perioperative analgesia in addition to a bilateral intraoral glossopharyngeal nerve block with 0.25% bupivacaine. Receives: Procedure: Bilateral Intraoral Glossopharyngeal Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between Perfusion Index and FLACC Pain Score
The correlation between postoperative perfusion index and the Face, Legs, Activity, Cry, Consolability (FLACC) Scale score will be evaluated in children aged 1-3 years. The FLACC Scale ranges from 0 to 10, with higher scores indicating greater pain intensity. Perfusion index will be calculated as the mean of three consecutive measurements obtained from the right index finger. The reported outcome will be the correlation coefficient between postoperative perfusion index and the FLACC Scale score.
Measured: During the postoperative recovery period, up to 30 minutes after admission to the post-anesthesia care unit.
Correlation Between Perfusion Index and Wong-Baker FACES Pain Score
The correlation between postoperative perfusion index and the Wong-Baker FACES Pain Rating Scale score will be evaluated in children older than 3 years. The Wong-Baker FACES Pain Rating Scale ranges from 0 to 10, with higher scores indicating greater pain intensity. Perfusion index will be calculated as the mean of three consecutive measurements obtained from the right index finger. The reported outcome will be the correlation coefficient between postoperative perfusion index and the Wong-Baker FACES Pain Rating Scale score.
Measured: During the postoperative recovery period, up to 30 minutes after admission to the post-anesthesia care unit.
Secondary outcomes (8)
Change in Perfusion Index During the Perioperative Period
Perfusion index values will be recorded at predefined perioperative time points, including the preoperative baseline, 20 minutes after tracheal intubation, upon admission to the PACU, and before discharge from the PACU. Three consecutive measurements will be obtained at each time point and the mean value will be used for analysis. Changes in PI over time and differences between the study groups will be evaluated.
Measured: At preoperative baseline, 20 minutes after tracheal intubation, upon admission to the post-anesthesia care unit, and before discharge from the post-anesthesia care unit on the day of surgery.
Postoperative Pain Score
Postoperative pain severity will be assessed using age-appropriate validated pediatric pain scales. The FLACC scale will be used in children aged 1-3 years, and the Wong-Baker FACES Pain Rating Scale will be used in children older than 3 years. Both scales range from 0 to 10, with higher scores indicating greater pain intensity.
Measured: Approximately 30 minutes after admission to the PACU
Requirement for Rescue Analgesia
The number and proportion of participants requiring rescue analgesia during postoperative recovery will be recorded. Intravenous ibuprofen 10 mg/kg will be administered according to the predefined postoperative pain criteria.
Measured: During the PACU stay on the day of surgery
Incidence of Postoperative Nausea and Vomiting
The incidence of postoperative nausea and/or vomiting will be recorded during postoperative recovery.
Measured: During the PACU stay on the day of surgery
Perioperative Heart Rate
Heart rate, measured in beats per minute, will be recorded at predefined perioperative time points, including the preoperative baseline, 20 minutes after tracheal intubation, before extubation, and during admission to and discharge from the PACU.
Measured: At preoperative baseline, 20 minutes after tracheal intubation, upon admission to the post-anesthesia care unit, and before discharge from the post-anesthesia care unit on the day of surgery.
Perioperative Systolic Blood Pressure
Systolic blood pressure, measured in mmHg, will be recorded at predefined perioperative time points, including the preoperative baseline, 20 minutes after tracheal intubation, before extubation, and during admission to and discharge from the PACU.
Measured: At preoperative baseline, 20 minutes after tracheal intubation, upon admission to the post-anesthesia care unit, and before discharge from the post-anesthesia care unit on the day of surgery.
Perioperative Diastolic Blood Pressure
Diastolic blood pressure , measured in mmHg, will be recorded at predefined perioperative time points, including the preoperative baseline, 20 minutes after tracheal intubation, before extubation, and during admission to and discharge from the PACU.
Measured: At preoperative baseline, 20 minutes after tracheal intubation, upon admission to the post-anesthesia care unit, and before discharge from the post-anesthesia care unit on the day of surgery.
Peripheral Oxygen Saturation
Peripheral oxygen saturation, expressed as a percentage, will be recorded at predefined perioperative time points, including the preoperative baseline, 20 minutes after tracheal intubation, before extubation, and during admission to and discharge from the PACU.
Measured: At preoperative baseline, 20 minutes after tracheal intubation, upon admission to the post-anesthesia care unit, and before discharge from the post-anesthesia care unit on the day of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start5 Oct 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet Altun, Istanbul University
- Investigators
- Salih A AKINCI, Research Assistant, Principal investigator, Istanbul UniversityDemet A ALTUN BINGOL, Study Director, Study director, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915804
- Sponsor's protocol ID
- 2025/1414
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postoperative Pain With Perfusion Index Measurement in Pediatric Adenotonsillectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07915804
- Acronym / sponsor ID
- 2025/1414
- Conditions
- Postoperative Pain, Adenotonsillectomy, Pain, Pediatric
- Keywords
- perfusion index, glossopharyngeal nerve block, FLACC, Wong-Baker FACES, objective pain assessment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 5 Oct 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial aims to evaluate the usefulness of the perfusion index (PI) as an objective measure of postoperative pain in children aged 1-12 years undergoing adenotonsillectomy. Participants will be randomized into two groups: a control group receiving standard general anesthesia and multimodal analgesia, and an intervention group receiving an additional bilateral glossopharyngeal nerve block with 0.25% bupivacaine. Postoperative PI measurements will be compared with validated pediatric pain scales, including the Face, Legs, Activity, Cry, Consolability (FLACC) and Wong-Baker FACES scales.
Detailed description
This single-center, prospective, randomized controlled study will include 50 pediatric patients aged 1-12 years with American Society of Anesthesiologists (ASA) physical status I-II scheduled for elective adenotonsillectomy. Participants will be randomized in a 1:1 ratio using sealed envelopes into a control group and a glossopharyngeal nerve block group.
All patients will receive A standardized anesthetic protocol will be applied to all participants. Inhalational induction of anesthesia will be initiated with sevoflurane using a fresh gas flow of 12 L/min and an inspired oxygen concentration of approximately 92%, with sevoflurane at 8%. After intravenous access is established, fentanyl 2 µg/kg and rocuronium 0.4 mg/kg will be administered to facilitate tracheal intubation.
The operating room temperature will be maintained between 20°C and 23°C throughout the procedure in order to minimize the potential influence of ambient temperature on peripheral perfusion. All patients will also receive active forced-air warming intraoperatively.
As part of the standardized perioperative management, all participants will receive ampicillin-sulbactam 25 mg/kg for surgical antimicrobial prophylaxis, dexamethasone 0.1 mg/kg, methylprednisolone 1 mg/kg, and paracetamol 15 mg/kg.
In the intervention group, a bilateral intraoral glossopharyngeal nerve block will be performed after induction of general anesthesia using 0.25% bupivacaine at a total dose of 0.2 mL/kg, divided equally between both sides, following negative aspiration and injection into the anterior or posterior tonsillar pillars.
Baseline PI measurements will be obtained preoperatively from the right index finger. Additional PI measurements will be obtained 20 minutes after tracheal intubation and during the postoperative recovery period. PI will also be assessed upon admission to and before discharge from the post-anesthesia care unit (PACU). At each measurement point, three consecutive readings will be recorded and their mean value will be used for statistical analysis.
Postoperative pain will be assessed using the FLACC scale in 1-3 years children and the Wong-Baker FACES Pain Rating Scale in 4-12 children. In both rating scales patients with a pain score of 6 or greater will receive intravenous ibuprofen at a dose of 10 mg/kg. Pain assessments will be performed during the postoperative recovery period, including after approximately 30 minutes of observation in the PACU. Vital signs, postoperative nausea and vomiting (PONV), rescue analgesic requirements, and other postoperative complications will also be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Control) | No intervention | –standard general anesthesia and multimodal analgesia, no nerve block |
| Group 2 (Glossopharyngeal Nerve Block) | Experimental | Procedure: Bilateral Intraoral Glossopharyngeal Nerve BlockParticipants in this group will receive standardized general anesthesia and multimodal perioperative analgesia in addition to a bilateral intraoral glossopharyngeal nerve block with 0.25% bupivacaine. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pediatric patients aged 1-12 years
- Scheduled to undergo elective adenotonsillectomy
- American Society of Anesthesiologists (ASA) physical status I-II
- Written informed consent obtained from a parent or legal guardian
Key exclusion criteria (8 listed)
- American Society of Anesthesiologists (ASA) physical status III or higher
- Perioperative hemodynamic instability
- Perioperative respiratory instability
- Known allergy to local anesthetic agents
- Chronic pain or neurological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral Intraoral Glossopharyngeal Nerve BlockAfter induction of general anesthesia, a bilateral intraoral glossopharyngeal nerve block will be performed using 0.25% bupivacaine at a total volume of 0.2 mL/kg, divided equally between both sides. Following negative aspiration, the local anesthetic will be injected into the anterior or posterior tonsillar pillars bilaterally. | Procedure or surgery | Group 2 (Glossopharyngeal Nerve Block) |
Primary outcome
Correlation Between Perfusion Index and FLACC Pain Score
Time frame: During the postoperative recovery period, up to 30 minutes after admission to the post-anesthesia care unit.
The correlation between postoperative perfusion index and the Face, Legs, Activity, Cry, Consolability (FLACC) Scale score will be evaluated in children aged 1-3 years. The FLACC Scale ranges from 0 to 10, with higher scores indicating greater pain intensity. Perfusion index will be calculated as the mean of three consecutive measurements obtained from the right index finger. The reported outcome will be the correlation coefficient between postoperative perfusion index and the FLACC Scale score.
Correlation Between Perfusion Index and Wong-Baker FACES Pain Score
Time frame: During the postoperative recovery period, up to 30 minutes after admission to the post-anesthesia care unit.
The correlation between postoperative perfusion index and the Wong-Baker FACES Pain Rating Scale score will be evaluated in children older than 3 years. The Wong-Baker FACES Pain Rating Scale ranges from 0 to 10, with higher scores indicating greater pain intensity. Perfusion index will be calculated as the mean of three consecutive measurements obtained from the right index finger. The reported outcome will be the correlation coefficient between postoperative perfusion index and the Wong-Baker FACES Pain Rating Scale score.
8 secondary outcomes
Change in Perfusion Index During the Perioperative Period
Time frame: At preoperative baseline, 20 minutes after tracheal intubation, upon admission to the post-anesthesia care unit, and before discharge from the post-anesthesia care unit on the day of surgery.
Postoperative Pain Score
Time frame: Approximately 30 minutes after admission to the PACU
Requirement for Rescue Analgesia
Time frame: During the PACU stay on the day of surgery
Incidence of Postoperative Nausea and Vomiting
Time frame: During the PACU stay on the day of surgery
Perioperative Heart Rate
Time frame: At preoperative baseline, 20 minutes after tracheal intubation, upon admission to the post-anesthesia care unit, and before discharge from the post-anesthesia care unit on the day of surgery.
Perioperative Systolic Blood Pressure
Time frame: At preoperative baseline, 20 minutes after tracheal intubation, upon admission to the post-anesthesia care unit, and before discharge from the post-anesthesia care unit on the day of surgery.
Perioperative Diastolic Blood Pressure
Time frame: At preoperative baseline, 20 minutes after tracheal intubation, upon admission to the post-anesthesia care unit, and before discharge from the post-anesthesia care unit on the day of surgery.
Peripheral Oxygen Saturation
Time frame: At preoperative baseline, 20 minutes after tracheal intubation, upon admission to the post-anesthesia care unit, and before discharge from the post-anesthesia care unit on the day of surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Salih A AKINCI, Research Assistant principal investigator
Istanbul University
Demet A ALTUN BINGOL, Study Director study director
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral Intraoral Glossopharyngeal Nerve Block in people with Postoperative Pain and Adenotonsillectomy, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salih A AKINCI, Research Assistant (+905524338021, salih.akinci@istanbul.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between Perfusion Index and FLACC Pain Score (time frame: During the postoperative recovery period, up to 30 minutes after admission to the post-anesthesia care unit.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.