TonsillectomyNCT07825922
Analgesic Efficacy of Peritonsillar Ropivacaine Infiltration After Tonsillectomy in Children
A study testing Peritonsillar infiltration with ropivacaine, Peritonsillar infiltration with normal saline and Normal Saline in people with Tonsillectomy and Ropivacaine, run by University Hospital, Mahdia at 1 site in Tunisia.
Trial summary
Tonsillectomy is one of the most frequently performed surgical procedures in children and is commonly associated with significant postoperative pain. Peritonsillar infiltration with local anesthetics such as Ropivacaine has been proposed to improve analgesia, but evidence remains inconsistent. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Tonsillectomy, Ropivacaine, Analgesia
- What is being tested?
- Peritonsillar infiltration with ropivacaine, Peritonsillar infiltration with normal saline and Normal Saline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Mar 2024to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 3-6 years
- classified as ASA I-II
- scheduled for elective tonsillectomy without adenoidectomy
Who cannot join
- systemic diseases (hepatic, renal, hematologic, or cardiac)
- obesity (BMI ≥ 95th percentile)
- upper respiratory infection within two weeks
- chronic analgesic use
- known allergy to local anesthetics
Trial locations and contacts
1 site in 1 country.
About this study
Tonsillectomy is one of the most frequently performed surgical procedures in children and is commonly associated with significant postoperative pain. Peritonsillar infiltration with local anesthetics such as Ropivacaine has been proposed to improve analgesia, but evidence remains inconsistent. This study aimed to evaluate the analgesic efficacy of peritonsillar Ropivacaine infiltration in pediatric tonsillectomy.
- Conditions
- Tonsillectomy, Ropivacaine, Analgesia, Local Anesthesia, Children
- Being tested
- Peritonsillar infiltration with ropivacaine, Peritonsillar infiltration with normal saline, Normal Saline, ropivacaine (local infiltration)
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peritonsillar infiltration with ropivacaineOther
Under general anesthesia and before surgical incision, the patient was positioned in Rose's position. Infiltration with ropivacaine was performed after intubation and before incision at three points (superior, middle, and inferior poles, including the posterior pillar), using a 23 gauge needle inserted between the pharyngeal muscles and tonsillar capsule.
Peritonsillar infiltration with normal salineOther
Under general anesthesia and before surgical incision, the patient was positioned in Rose's position. Infiltration with normal saline was performed after intubation and before incision at three points (superior, middle, and inferior poles, including the posterior pillar), using a 23 gauge needle inserted between the pharyngeal muscles and tonsillar capsule.
Normal SalineDrug
Normal saline 0.9%, 5 mL, administered (2.5 mL per tonsillar bed)
ropivacaine (local infiltration)Drug
Ropivacaine 0.2%, 5 mL, administered (2.5 mL per tonsillar bed)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Placebo) | Placebo comparator | patients will receive peritonsillar infiltration with normal saline Receives: Other: Peritonsillar infiltration with normal saline; Drug: Normal Saline |
| Group 2 (Ropivacaine) | Active comparator | patients will receive peritonsillar infiltration with ropivacaine Receives: Other: Peritonsillar infiltration with ropivacaine; Drug: ropivacaine (local infiltration) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first postoperative analgesic request
Time from the end of surgery to the first administration of rescue analgesic medication. The time was recorded in hours.
Measured: From the end of surgery until 24 hours postoperatively
Secondary outcomes (11)
Intraoperative remifentanil dose (µg)
It refers to the total dose of remifentanil administered to the patient during the entire surgical procedure. It reflects the amount of opioid used for intraoperative analgesia.
Measured: Perioperative.
Paracetamol Consumption at 24h
It refers to the total dose of paracetamol consumed in the first 24 hours postoperatively, normalized per kilogram of body weight (mg/kg).
Measured: In the first 24 hours postoperatively
Time to first oral intake
Time from the end of surgery to the first oral intake, expressed in hours.
Measured: From the end of surgery until first oral intake, assessed during the first 24 hours after surgery.
Face, Legs, Activity, Cry, Consolability scores over 24h
Postoperative pain intensity assessed using the Face, Legs, Activity, Cry, Consolability scale (FLACC), ranging from 0 (no pain) to 10 (worst possible pain).
Measured: At 0, 2, 4, 8, 12 and 24 hours after surgery
Parental satisfaction
Parents' satisfaction was assessed using a 5-point Likert scale, where 1 indicated very dissatisfied, 5 very satisfied.
Measured: At 24 hours after surgery
Incidence of adverse effects
Occurrence of adverse effects (hypotension, bradycardia, arrhythmia, or local anesthetic toxicity) during or after surgery.
Measured: Perioperative.
Need for rescue tramadol
Once the FLACC score will be ≥ 4, rescue analgesia in the form of tramadol will be given.
Measured: Perioperative.
Surgical conditions
It refers to the surgical dissection evaluated by the surgeon, easy, moderately easy or hard.
Measured: Perioperative.
Intraoperative systolic blood pressure
It refers to the the systolic blood pressure collected intraoperatively every ten minutes.
Measured: Perioperative.
Intraoperative diastolic blood pressure.
It refers to the diastolic blood pressure collected intraoperatively every ten minutes.
Measured: Perioperative.
Intraoperative heart rate
It refers to the heart rate collected intraoperatively every ten minutes.
Measured: Perioperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Mar 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillectomyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be randomized to be allocated to 2 groups by a computer-generated randomization table into two equal groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Mahdia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hela Attia, University Hospital, Mahdia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825922
- Sponsor's protocol ID
- CEM-2024-02-07
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Peritonsillar Ropivacaine Infiltration After Tonsillectomy in Children
- ClinicalTrials.gov ID
- NCT07825922
- Acronym / sponsor ID
- CEM-2024-02-07
- Conditions
- Tonsillectomy, Ropivacaine, Analgesia, Local Anesthesia, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, MahdiaUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 17 Sep 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.
Tonsillectomy is one of the most frequently performed surgical procedures in children and is commonly associated with significant postoperative pain. Peritonsillar infiltration with local anesthetics such as Ropivacaine has been proposed to improve analgesia, but evidence remains inconsistent. This study aimed to evaluate the analgesic efficacy of peritonsillar Ropivacaine infiltration in pediatric tonsillectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The patients will be randomized to be allocated to 2 groups by a computer-generated randomization table into two equal groups
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Placebo) | Placebo comparator | Other: Peritonsillar infiltration with normal saline, Drug: Normal Salinepatients will receive peritonsillar infiltration with normal saline |
| Group 2 (Ropivacaine) | Active comparator | Other: Peritonsillar infiltration with ropivacaine, Drug: ropivacaine (local infiltration)patients will receive peritonsillar infiltration with ropivacaine |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 3-6 years
- classified as ASA I-II
- scheduled for elective tonsillectomy without adenoidectomy
Key exclusion criteria (5 listed)
- systemic diseases (hepatic, renal, hematologic, or cardiac)
- obesity (BMI ≥ 95th percentile)
- upper respiratory infection within two weeks
- chronic analgesic use
- known allergy to local anesthetics
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 |
|---|---|---|
| Peritonsillar infiltration with ropivacaineUnder general anesthesia and before surgical incision, the patient was positioned in Rose's position. Infiltration with ropivacaine was performed after intubation and before incision at three points (superior, middle, and inferior poles, including the posterior pillar), using a 23 gauge needle inserted between the pharyngeal muscles and tonsillar capsule. | Other | Group 2 (Ropivacaine) |
| Peritonsillar infiltration with normal salineUnder general anesthesia and before surgical incision, the patient was positioned in Rose's position. Infiltration with normal saline was performed after intubation and before incision at three points (superior, middle, and inferior poles, including the posterior pillar), using a 23 gauge needle inserted between the pharyngeal muscles and tonsillar capsule. | Other | Group 1 (Placebo) |
| Normal SalineNormal saline 0.9%, 5 mL, administered (2.5 mL per tonsillar bed) | Drug | Group 1 (Placebo) |
| ropivacaine (local infiltration)Ropivacaine 0.2%, 5 mL, administered (2.5 mL per tonsillar bed) | Drug | Group 2 (Ropivacaine) |
Primary outcome
Time to first postoperative analgesic request
Time frame: From the end of surgery until 24 hours postoperatively
Time from the end of surgery to the first administration of rescue analgesic medication. The time was recorded in hours.
11 secondary outcomes
Intraoperative remifentanil dose (µg)
Time frame: Perioperative.
Paracetamol Consumption at 24h
Time frame: In the first 24 hours postoperatively
Time to first oral intake
Time frame: From the end of surgery until first oral intake, assessed during the first 24 hours after surgery.
Face, Legs, Activity, Cry, Consolability scores over 24h
Time frame: At 0, 2, 4, 8, 12 and 24 hours after surgery
Parental satisfaction
Time frame: At 24 hours after surgery
Incidence of adverse effects
Time frame: Perioperative.
Need for rescue tramadol
Time frame: Perioperative.
Surgical conditions
Time frame: Perioperative.
Intraoperative systolic blood pressure
Time frame: Perioperative.
Intraoperative diastolic blood pressure.
Time frame: Perioperative.
Intraoperative heart rate
Time frame: Perioperative.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peritonsillar infiltration with ropivacaine, Peritonsillar infiltration with normal saline and Normal Saline in people with Tonsillectomy and Ropivacaine, run by University Hospital, Mahdia at 1 site in Tunisia.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 17 Sep 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 Tunisia. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first postoperative analgesic request (time frame: From the end of surgery until 24 hours postoperatively). 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 17 Sep 2026.