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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Marzieh Beigom khezri, assistant professor contact

+98 9123811009

mkhezri@qums.ac.ir

Iran1 site, 1 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

    Recruiting

Other trials in Iran

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 groups in NCT01198210
Study groupRoleWhat they receive
salinePlacebo comparatorOne 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
ketamineActive comparatorOne 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
dexamethasoneActive comparatorOne 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-ketamineActive comparatorOne 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.

  1. 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)

  2. 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))

  3. 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))

  4. 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))

  5. 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))

  6. postoperative analgesic consumption

    Measured: during 24 h postoperative (in the ward)

Secondary outcomes (4)
  1. nausea, vomiting will be assessed by questioning their parents.

    Measured: during 60th min after extubation at postanesthesia care unit

  2. bleeding will be assessed by questioning their parents

    Measured: during 24 h postoperative (in the ward)

  3. family satisfaction will be assessed by questioning their parents.

    Measured: during 24 h postoperative (in the ward).

  4. 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.

  1. First posted10 Sep 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionNov 2013 (estimated)
  4. Study completionDec 2013 (estimated)

Resources

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)
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

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.

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