The Effect of Peritonsillar Infiltration of Ketamine and Dexamethasone for Postoperative Pain Relief in Children Following Adenotonsillectomy

NCT01198210 | Unknown Phase 1 DMC

• 1 other identifier: ACTRN12610000658011
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

pain; tonsillectomy; peritonsillar infiltration; postoperative pain

Outcome Measures

Primary Outcomes (6)

• pain will be assessed by [observational pain scores (OPS)]

  5 minutes After extubation when the patients were taken to the postanesthesia care unit (PACU)

• pain will be assessed by [observational pain scores (OPS)]

  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)]

  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)]

  60thmin postoperatively (60 minutes After extubation when the patients were taken to the postanesthesia care unit (PACU))

• time to first demand of analgesia

  during 60min postoperatively (during 60 minutes After extubation when the patients were taken to the postanesthesia care unit (PACU))

• postoperative analgesic consumption

  during 24 h postoperative (in the ward)

Secondary Outcomes (4)

• nausea, vomiting will be assessed by questioning their parents.

  during 60th min after extubation at postanesthesia care unit

• bleeding will be assessed by questioning their parents

  during 24 h postoperative (in the ward)

• family satisfaction will be assessed by questioning their parents.

  during 24 h postoperative (in the ward).

• nausea, vomiting will be assessed by questioning their parents.

  during 24 h postoperative (in the ward)

Study Arms (4)

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).

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).

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).

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).

Drug: ketamine-dexamethasone

Interventions

saline DRUG

local peritonsillar infiltration of 2 ml saline,

saline

Ketamine DRUG

local peritonsillar infiltration of ketamine (0.5 mg/kg)

ketamine

Dexamethasone DRUG

local peritonsillar infiltration dexamethasone (0.2 mg/kg))

dexamethasone

ketamine-dexamethasone DRUG

local peritonsillar infiltration combination of ketamine0.5mg/kg-dexamethason 0.2mg/kg

dexamethasone-ketamine

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children age 3-12 years ASAI,II

You may not qualify if:

• 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, -

Sponsors & Collaborators

• Qazvin University Of Medical Sciences: lead

Study Sites (1)

Qazvin university of medical science

Qazvin, Qazvin Province, 34197/59811, Iran

RECRUITING

MeSH Terms

Conditions

Pain; Pain, Postoperative

Interventions

Sodium Chloride; Ketamine; Dexamethasone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Marzieh Beigom khezri, assistant professor

CONTACT

+98 9123811009; mkhezri@qums.ac.ir

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: September 1, 2010
• First Posted: September 10, 2010
• Study Start: July 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 7, 2013

Record last verified: 2013-05

Locations

IR (1)