TonsillectomyPhase 1/2NCT01198210
The Effect of Peritonsillar Infiltration of Ketamine and Dexamethasone for Postoperative Pain Relief in Children Following Adenotonsillectomy
A Phase 1/2 study testing saline, Ketamine and Dexamethasone in people with Tonsillectomy, run by Qazvin University Of Medical Sciences at 1 site in Iran.
Trial summary
The immediate postoperative period after tonsillectomy, , is often difficult. These children frequently have severe pain but postoperative airway edema along with increased sensitivity to the respiratory-depressant effects of opioids may result in obstructive symptoms and hypoxemia. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Tonsillectomy
- What is being tested?
- saline, Ketamine and Dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteIran
- Study dates
- Jul 2010to Dec 2013
- Phase
- Phase 1/2
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children age 3-12 years ASAI,II
Who cannot join
- contraindication for usage of Ketamine, dexamethasone
- upper respiratory tract infection
- increase intracranial pressure( ICP)
- history of allergy ,seizure,psychiatric illness, , bleeding disorders
- chronic usage of analgesic ,antiemetic ,stroied drugs two weeks before surgery,
- history of peritonsillar abscess, , tonsillitis within two weeks, -
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Qazvin university of medical science
Qazvin, Qazvin Province, 34197/59811
Marzieh Beigomb Khezri, assistant professor, +98 9123811009, mkhezri@qums.ac.ir
Marzieh Beigom Khezri, assistant professor
About this study
Official title: Comparison of Peritonsillar Infiltration of Ketamine and Dexamethasone for Postoperative Pain Relief in Children Following Adenotonsillectomy
The immediate postoperative period after tonsillectomy, , is often difficult. These children frequently have severe pain but postoperative airway edema along with increased sensitivity to the respiratory-depressant effects of opioids may result in obstructive symptoms and hypoxemia. Opioid consumption may be reduced by non-steroidal anti-inflammatory drugs, but these drugs may be associated with increased bleeding after this operation.
Methods: One hundred sixty ASA I-II children 3-12 were randomized four groups of 40 each. Group P received a local peritonsillar infiltration of 2 ml saline, group D dexamethsone (0.2 mg/kg)) , group K ketamine (0.5 mg/kg) and group KD combination of ketamine0.5mg/kg dexamethasone 0.2mg/kg. All medications were 2 ml in volume which was applied 1 ml per tonsil 3 min prior to tonsillectomy. Study drugs were marked only with a coded number label. A computer-generated table of numbers guided randomization. Modified Hannallah pain scale [observational pain scores (OPS)], nausea, vomiting, bleeding, rescue analgesia, sedation and Aldrete scores were recorded at first, 15th, 30th and 60th min postoperatively. Patients were interviewed on the day after surgery to assess the postoperative pain, nightmares, hallucinations, vomiting and bleeding. All the children were premedicated with midazolam hydrochloride 0.3 mg/kg) and fentanyl 1micro g/kg intavenously. Anesthesia was induced with thiopental 5mg/kg and atracurium0.3mg/kg. Anesthesia was maintained with isoflurane 1.5% and nitrous oxide 30% in oxygen. The two surgeon used the same dissection and snare technique for all cases and hemostasis done with bipolar cutter. At the end of the surgery neuromuscular blockade was reversed by neostigmine 0.03 mg/kg) and atropine 0.01 mg/kg intravenously), anesthesia was discontinued and the tracheal tube removed in the operating room when patients were deep. After extubation the patients were taken to the postanesthesia care unit (PACU) where an nurse who were unaware of the study drug observed the patients. The pain scoring observer nurse in PACU was consistent. Time to awaken (from the end of anesthesia until the patients opened their eyes on command) and time to the first administration of postoperative analgesia were recorded. Pethidine in a titrated dose (total 1 mg/kg) was administered intravenously for rapid pain relief to patients with a OPS score > 4 or who were crying during two consecutive five minute observation periods until the child was comfortable. Postoperative pain during the first 24 h was assessed using a four-point scale: 0 no pain, 1 mild pain, 2 moderate pain, 3 severe pain by questioning their parents. In the ward the standardized postoperative analgesic technique was with acetaminophen supp (40 mg/kg followed by three doses of 20 mg/kg at 6-hour intervals to be given as needed for pain. Pethidine in a titrated dose (total 1 mg/kg) was administered intravenously for rapid pain relief to patients who had pain scale >3.Any supplementary analgesia , nausea and vomiting, bleeding, sleep disturbance and nightmares that the child might have had as surgery were assessed during a telephone follow up 24 h later.
- Conditions
- Tonsillectomy
- Being tested
- saline, Ketamine, Dexamethasone, ketamine-dexamethasone
- Keywords
- pain, tonsillectomy, peritonsillar infiltration, postoperative pain
- Medical subject headings
- Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salineDrug
local peritonsillar infiltration of 2 ml saline,
KetamineDrug
local peritonsillar infiltration of ketamine (0.5 mg/kg)
DexamethasoneDrug
local peritonsillar infiltration dexamethasone (0.2 mg/kg))
ketamine-dexamethasoneDrug
local peritonsillar infiltration combination of ketamine0.5mg/kg-dexamethason 0.2mg/kg
| Study group | Role | What they receive |
|---|---|---|
| saline | Placebo comparator | One hundred sixtyAmerican Society of Anesthesiologists (ASA) I-II children 3-12 were randomized four groups of 40 each. Group P received a local peritonsillar infiltration of 2 ml saline, group D dexamethsone (0.2 mg/kg)) , group K ketamine (0.5 mg/kg) and group KD combination of ketamine0.5mg/kg-dexamethasone 0.2mg/kg. All medications were 2 ml in volume which was applied 1 ml per tonsil 3 min prior to tonsillectomy( all four groups). Receives: Drug: saline |
| ketamine | Active comparator | One hundred sixtyAmerican Society of Anesthesiologists (ASA) I-II children 3-12 were randomized four groups of 40 each. Group P received a local peritonsillar infiltration of 2 ml saline, group D dexamethsone (0.2 mg/kg)) , group K ketamine (0.5 mg/kg) and group KD combination of ketamine0.5mg/kg-dexamethasone 0.2mg/kg. All medications were 2 ml in volume which was applied 1 ml per tonsil 3 min prior to tonsillectomy( all four groups). Receives: Drug: Ketamine |
| dexamethasone | Active comparator | One hundred sixtyAmerican Society of Anesthesiologists (ASA) I-II children 3-12 were randomized four groups of 40 each. Group P received a local peritonsillar infiltration of 2 ml saline, group D dexamethsone (0.2 mg/kg)) , group K ketamine (0.5 mg/kg) and group KD combination of ketamine0.5mg/kg-dexamethasone 0.2mg/kg. All medications were 2 ml in volume which was applied 1 ml per tonsil 3 min prior to tonsillectomy( all four groups). Receives: Drug: Dexamethasone |
| dexamethasone-ketamine | Active comparator | One hundred sixtyAmerican Society of Anesthesiologists (ASA) I-II children 3-12 were randomized four groups of 40 each. Group P received a local peritonsillar infiltration of 2 ml saline, group D dexamethsone (0.2 mg/kg)) , group K ketamine (0.5 mg/kg) and group KD combination of ketamine0.5mg/kg-dexamethasone 0.2mg/kg. All medications were 2 ml in volume which was applied 1 ml per tonsil 3 min prior to tonsillectomy( all four groups). Receives: Drug: ketamine-dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain will be assessed by [observational pain scores (OPS)]
Measured: 5 minutes After extubation when the patients were taken to the postanesthesia care unit (PACU)
pain will be assessed by [observational pain scores (OPS)]
Measured: 15th min postoperatively (15 minutes After extubation when the patients were taken to the postanesthesia care unit (PACU))
pain will be assessed by [observational pain scores (OPS)]
Measured: 30th min postoperatively (30 minutes After extubation when the patients were taken to the postanesthesia care unit (PACU))
pain will be assessed by [observational pain scores (OPS)]
Measured: 60thmin postoperatively (60 minutes After extubation when the patients were taken to the postanesthesia care unit (PACU))
time to first demand of analgesia
Measured: during 60min postoperatively (during 60 minutes After extubation when the patients were taken to the postanesthesia care unit (PACU))
postoperative analgesic consumption
Measured: during 24 h postoperative (in the ward)
Secondary outcomes (4)
nausea, vomiting will be assessed by questioning their parents.
Measured: during 60th min after extubation at postanesthesia care unit
bleeding will be assessed by questioning their parents
Measured: during 24 h postoperative (in the ward)
family satisfaction will be assessed by questioning their parents.
Measured: during 24 h postoperative (in the ward).
nausea, vomiting will be assessed by questioning their parents.
Measured: during 24 h postoperative (in the ward)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startJul 2010
- Primary completionNov 2013 (estimated)
- Study completionDec 2013 (estimated)
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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qazvin University Of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, marzieh beigom khezri, Qazvin University Of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198210
- Sponsor's protocol ID
- ACTRN12610000658011
- Status last verified
- May 2013
- First submitted
- 1 Sep 2010
- Last updated
- 7 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Peritonsillar Infiltration of Ketamine and Dexamethasone for Postoperative Pain Relief in Children Following Adenotonsillectomy
- ClinicalTrials.gov ID
- NCT01198210
- Acronym / sponsor ID
- ACTRN12610000658011
- Conditions
- Tonsillectomy
- Keywords
- pain, tonsillectomy, peritonsillar infiltration, postoperative pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Qazvin University Of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 10 Sep 2010 (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 immediate postoperative period after tonsillectomy, , is often difficult. These children frequently have severe pain but postoperative airway edema along with increased sensitivity to the respiratory-depressant effects of opioids may result in obstructive symptoms and hypoxemia. Opioid consumption may be reduced by non-steroidal anti-inflammatory drugs, but these drugs may be associated with increased bleeding after this operation.
Methods: One hundred sixty ASA I-II children 3-12 were randomized four groups of 40 each. Group P received a local peritonsillar infiltration of 2 ml saline, group D dexamethsone (0.2 mg/kg)) , group K ketamine (0.5 mg/kg) and group KD combination of ketamine0.5mg/kg dexamethasone 0.2mg/kg. All medications were 2 ml in volume which was applied 1 ml per tonsil 3 min prior to tonsillectomy. Study drugs were marked only with a coded number label. A computer-generated table of numbers guided randomization. Modified Hannallah pain scale [observational pain scores (OPS)], nausea, vomiting, bleeding, rescue analgesia, sedation and Aldrete scores were recorded at first, 15th, 30th and 60th min postoperatively. Patients were interviewed on the day after surgery to assess the postoperative pain, nightmares, hallucinations, vomiting and bleeding. All the children were premedicated with midazolam hydrochloride 0.3 mg/kg) and fentanyl 1micro g/kg intavenously. Anesthesia was induced with thiopental 5mg/kg and atracurium0.3mg/kg. Anesthesia was maintained with isoflurane 1.5% and nitrous oxide 30% in oxygen. The two surgeon used the same dissection and snare technique for all cases and hemostasis done with bipolar cutter. At the end of the surgery neuromuscular blockade was reversed by neostigmine 0.03 mg/kg) and atropine 0.01 mg/kg intravenously), anesthesia was discontinued and the tracheal tube removed in the operating room when patients were deep. After extubation the patients were taken to the postanesthesia care unit (PACU) where an nurse who were unaware of the study drug observed the patients. The pain scoring observer nurse in PACU was consistent. Time to awaken (from the end of anesthesia until the patients opened their eyes on command) and time to the first administration of postoperative analgesia were recorded. Pethidine in a titrated dose (total 1 mg/kg) was administered intravenously for rapid pain relief to patients with a OPS score > 4 or who were crying during two consecutive five minute observation periods until the child was comfortable. Postoperative pain during the first 24 h was assessed using a four-point scale: 0 no pain, 1 mild pain, 2 moderate pain, 3 severe pain by questioning their parents. In the ward the standardized postoperative analgesic technique was with acetaminophen supp (40 mg/kg followed by three doses of 20 mg/kg at 6-hour intervals to be given as needed for pain. Pethidine in a titrated dose (total 1 mg/kg) was administered intravenously for rapid pain relief to patients who had pain scale >3.Any supplementary analgesia , nausea and vomiting, bleeding, sleep disturbance and nightmares that the child might have had as surgery were assessed during a telephone follow up 24 h later.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| saline | Placebo comparator | Drug: salineOne hundred sixtyAmerican Society of Anesthesiologists (ASA) I-II children 3-12 were randomized four groups of 40 each. Group P received a local peritonsillar infiltration of 2 ml saline, group D dexamethsone (0.2 mg/kg)) , group K ketamine (0.5 mg/kg) and group KD combination of ketamine0.5mg/kg-dexamethasone 0.2mg/kg. All medications were 2 ml in volume which was applied 1 ml per tonsil 3 min prior to tonsillectomy( all four groups). |
| ketamine | Active comparator | Drug: KetamineOne hundred sixtyAmerican Society of Anesthesiologists (ASA) I-II children 3-12 were randomized four groups of 40 each. Group P received a local peritonsillar infiltration of 2 ml saline, group D dexamethsone (0.2 mg/kg)) , group K ketamine (0.5 mg/kg) and group KD combination of ketamine0.5mg/kg-dexamethasone 0.2mg/kg. All medications were 2 ml in volume which was applied 1 ml per tonsil 3 min prior to tonsillectomy( all four groups). |
| dexamethasone | Active comparator | Drug: DexamethasoneOne hundred sixtyAmerican Society of Anesthesiologists (ASA) I-II children 3-12 were randomized four groups of 40 each. Group P received a local peritonsillar infiltration of 2 ml saline, group D dexamethsone (0.2 mg/kg)) , group K ketamine (0.5 mg/kg) and group KD combination of ketamine0.5mg/kg-dexamethasone 0.2mg/kg. All medications were 2 ml in volume which was applied 1 ml per tonsil 3 min prior to tonsillectomy( all four groups). |
| dexamethasone-ketamine | Active comparator | Drug: ketamine-dexamethasoneOne hundred sixtyAmerican Society of Anesthesiologists (ASA) I-II children 3-12 were randomized four groups of 40 each. Group P received a local peritonsillar infiltration of 2 ml saline, group D dexamethsone (0.2 mg/kg)) , group K ketamine (0.5 mg/kg) and group KD combination of ketamine0.5mg/kg-dexamethasone 0.2mg/kg. All medications were 2 ml in volume which was applied 1 ml per tonsil 3 min prior to tonsillectomy( all four groups). |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children age 3-12 years ASAI,II
Key exclusion criteria (6 listed)
- contraindication for usage of Ketamine, dexamethasone
- upper respiratory tract infection
- increase intracranial pressure( ICP)
- history of allergy ,seizure,psychiatric illness, , bleeding disorders
- chronic usage of analgesic ,antiemetic ,stroied drugs two weeks before surgery,
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 |
|---|---|---|
| salinelocal peritonsillar infiltration of 2 ml saline, | Drug | saline |
| Ketaminelocal peritonsillar infiltration of ketamine (0.5 mg/kg) | Drug | ketamine |
| Dexamethasonelocal peritonsillar infiltration dexamethasone (0.2 mg/kg)) | Drug | dexamethasone |
| ketamine-dexamethasonelocal peritonsillar infiltration combination of ketamine0.5mg/kg-dexamethason 0.2mg/kg | Drug | dexamethasone-ketamine |
Primary outcome
pain will be assessed by [observational pain scores (OPS)]
Time frame: 5 minutes After extubation when the patients were taken to the postanesthesia care unit (PACU)
pain will be assessed by [observational pain scores (OPS)]
Time frame: 15th min postoperatively (15 minutes After extubation when the patients were taken to the postanesthesia care unit (PACU))
pain will be assessed by [observational pain scores (OPS)]
Time frame: 30th min postoperatively (30 minutes After extubation when the patients were taken to the postanesthesia care unit (PACU))
pain will be assessed by [observational pain scores (OPS)]
Time frame: 60thmin postoperatively (60 minutes After extubation when the patients were taken to the postanesthesia care unit (PACU))
time to first demand of analgesia
Time frame: during 60min postoperatively (during 60 minutes After extubation when the patients were taken to the postanesthesia care unit (PACU))
postoperative analgesic consumption
Time frame: during 24 h postoperative (in the ward)
4 secondary outcomes
nausea, vomiting will be assessed by questioning their parents.
Time frame: during 60th min after extubation at postanesthesia care unit
bleeding will be assessed by questioning their parents
Time frame: during 24 h postoperative (in the ward)
family satisfaction will be assessed by questioning their parents.
Time frame: during 24 h postoperative (in the ward).
nausea, vomiting will be assessed by questioning their parents.
Time frame: during 24 h postoperative (in the ward)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing saline, Ketamine and Dexamethasone in people with Tonsillectomy, run by Qazvin University Of Medical Sciences at 1 site in Iran.
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 6 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: status not confirmed, as of the sponsor's last update on 7 May 2013. 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 Iran. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marzieh Beigom khezri, assistant professor (+98 9123811009, mkhezri@qums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain will be assessed by [observational pain scores (OPS)] (time frame: 5 minutes After extubation when the patients were taken to the postanesthesia care unit (PACU)). The study lists 6 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 7 May 2013.