Peri-tonsillar Analgesic InfiltrationPhase 2NCT01552096
Tramadol Versus Lidocaine Infiltration for Tonsillectomy
A Phase 2 study testing peritonsillar infiltration in people with Peri-tonsillar Analgesic Infiltration and Tonsillectomy, run by Imam Abdulrahman Bin Faisal University at 2 sites in Saudi Arabia.
Trial summary
The investigators postulate that the use of pre-incisional peritonsillar infiltration of tramadol or lidocaine reduces both the inflammatory response and postoperative analgesic consumption, without harmful effects. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Peri-tonsillar Analgesic Infiltration, Tonsillectomy, Postoperative Pain
- What is being tested?
- peritonsillar infiltration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- Dec 2011to Nov 2013
- Phase
- Phase 2
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I \& II preschool children aged 2-6 years, undergoing elective tonsillectomy with or without adenoidectomy, under general anaesthesia. Indications for tonsillectomy will be chronic recurrent tonsillitis or tonsillar hypertrophy
Who cannot join
- Patients with a history of allergy to tramadol or amide local anaesthetics, epilepsy, or taking cardiovascular, antihypertensive, steroids, or anti-inflammatory medications, those with cardiac, liver, or kidney diseases, or any underlying systemic diseases or acute infectious processes will be excluded from the study. All operations will be performed, using an electro-dissection technique, by the same surgeon.
Trial locations and contacts
2 sites in 1 country.
Saudi Arabia2 sites
Dammam University KFHU
Khobar, EP, 31952
UD-KFHU
Khobar, EP, 31952
About this study
Official title: A Comparative Study of the Effects of Pre-incisional Infiltration of Tramadol or Lidocaine on the Inflammatory Response After Tonsillectomy.
The investigators postulate that the use of pre-incisional peritonsillar infiltration of tramadol or lidocaine reduces both the inflammatory response and postoperative analgesic consumption, without harmful effects. Therefore, the present study is designed to evaluate the effects of infiltration of tramadol or lidocaine on the postoperative acute-phase serum protein, C-reactive protein, and analgesic consumption after tonsillectomy.
- Conditions
- Peri-tonsillar Analgesic Infiltration, Tonsillectomy, Postoperative Pain, Inflammatory Response
- Being tested
- peritonsillar infiltration
- Keywords
- Anaesthesia, tonsillectomy, inflammatory response, stress response, tramadol, lidocaine
- Medical subject headings
- Pain, Postoperative, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peritonsillar infiltrationDrug
Also called as in description
1.5 ml around each tonsil, 3 minutes before surgical incision as per group description
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The placebo group (n=30) will receive a submucosal infiltration with 3 mL of normal saline (1.5 ml around each tonsil), 3 minutes before surgical incision. Receives: Drug: peritonsillar infiltration |
| lidocaine | Active comparator | will receive a total of 2 mg.kg-1 of 2% lidocaine HCl (Xylocaine, Astra-Zeneca,) in 3 mL of normal saline (1.5 ml around each tonsil), 5 minutes before surgical incision. Receives: Drug: peritonsillar infiltration |
| Tramadol | Experimental | (n=30) will receive a submucosal infiltration with 2 mg kg-1 tramadol in 3 mL of normal saline (1.5 ml around each tonsil), 3 minutes before surgical incision. Receives: Drug: peritonsillar infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
inflammatory and stress response
CRP Acute phase protein
Measured: 24 hours
Secondary outcomes (3)
Hemodynamic changes
MBP HR
Measured: 24 hours
pain score
VAS The time to first request for analgesia and the number of subjects receiving meperidine during the first 12 hours will be recorded.
Measured: 24 hours
Side-effects
postoperative stridor, laryngospasm, cyanosis, bleeding, seizures, sedation (four-point verbal rating scores (VRS): awake, drowsy, rousable or deep sleep); nausea and vomiting (0: no nausea; 1: nausea no vomiting; 2: nausea and vomiting), respiratory depression (ventilatory frequency 10), and desaturation (92%), at 0, 1, 2, 4, 6, 8, and 12 h after surgery.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startDec 2011
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-tonsillar Analgesic InfiltrationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- laila Telmesani, MD, Principal investigator, UDHany A. Mowafi, MD, Study chair, Associate ProfessorAlaa M. Khidr, MD, Study chair, Assistant ConsultantAbdulhadi Al'Saflan, MD, Study chair, Assistant Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552096
- Sponsor's protocol ID
- #2012082
- Status last verified
- Mar 2014
- First submitted
- 5 Mar 2012
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of the Effects of Pre-incisional Infiltration of Tramadol or Lidocaine on the Inflammatory Response After Tonsillectomy.
- ClinicalTrials.gov ID
- NCT01552096
- Acronym / sponsor ID
- #2012082
- Conditions
- Peri-tonsillar Analgesic Infiltration, Tonsillectomy, Postoperative Pain, Inflammatory Response
- Keywords
- Anaesthesia, tonsillectomy, inflammatory response, stress response, tramadol, lidocaine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 13 Mar 2012 (estimated)
- 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.
The investigators postulate that the use of pre-incisional peritonsillar infiltration of tramadol or lidocaine reduces both the inflammatory response and postoperative analgesic consumption, without harmful effects. Therefore, the present study is designed to evaluate the effects of infiltration of tramadol or lidocaine on the postoperative acute-phase serum protein, C-reactive protein, and analgesic consumption after tonsillectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: peritonsillar infiltrationThe placebo group (n=30) will receive a submucosal infiltration with 3 mL of normal saline (1.5 ml around each tonsil), 3 minutes before surgical incision. |
| lidocaine | Active comparator | Drug: peritonsillar infiltrationwill receive a total of 2 mg.kg-1 of 2% lidocaine HCl (Xylocaine, Astra-Zeneca,) in 3 mL of normal saline (1.5 ml around each tonsil), 5 minutes before surgical incision. |
| Tramadol | Experimental | Drug: peritonsillar infiltration(n=30) will receive a submucosal infiltration with 2 mg kg-1 tramadol in 3 mL of normal saline (1.5 ml around each tonsil), 3 minutes before surgical incision. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- ASA I \& II preschool children aged 2-6 years, undergoing elective tonsillectomy with or without adenoidectomy, under general anaesthesia. Indications for tonsillectomy will be chronic recurrent tonsillitis or tonsillar hypertrophy
Key exclusion criteria (1 listed)
- Patients with a history of allergy to tramadol or amide local anaesthetics, epilepsy, or taking cardiovascular, antihypertensive, steroids, or anti-inflammatory medications, those with cardiac, liver, or kidney diseases, or any underlying systemic diseases or acute infectious processes will be excluded from the study. All operations will be performed, using an electro-dissection technique, by the same surgeon.
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 infiltrationAlso: as in description1.5 ml around each tonsil, 3 minutes before surgical incision as per group description | Drug | Placebo, Tramadol, lidocaine |
Primary outcome
inflammatory and stress response
Time frame: 24 hours
CRP Acute phase protein
3 secondary outcomes
Hemodynamic changes
Time frame: 24 hours
pain score
Time frame: 24 hours
Side-effects
Time frame: 24 hours
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 18 Mar 2014.
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.
laila Telmesani, MD principal investigator
UD
Hany A. Mowafi, MD study chair
Associate Professor
Alaa M. Khidr, MD study chair
Assistant Consultant
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing peritonsillar infiltration in people with Peri-tonsillar Analgesic Infiltration and Tonsillectomy, run by Imam Abdulrahman Bin Faisal University at 2 sites in Saudi Arabia.
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 1 inclusion and 1 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 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Saudi Arabia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
inflammatory and stress response (time frame: 24 hours). 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 18 Mar 2014.