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

NCT ID: NCT01198210

Last Updated: 2013-05-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2013-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

saline

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).

Group Type: PLACEBO_COMPARATOR

saline

Intervention Type: DRUG

local peritonsillar infiltration of 2 ml saline,

ketamine

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).

Group Type: ACTIVE_COMPARATOR

Ketamine

Intervention Type: DRUG

local peritonsillar infiltration of ketamine (0.5 mg/kg)

dexamethasone

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).

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

local peritonsillar infiltration dexamethasone (0.2 mg/kg))

dexamethasone-ketamine

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).

Group Type: ACTIVE_COMPARATOR

ketamine-dexamethasone

Intervention Type: DRUG

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

Interventions

saline

local peritonsillar infiltration of 2 ml saline,

Intervention Type: DRUG

Ketamine

local peritonsillar infiltration of ketamine (0.5 mg/kg)

Intervention Type: DRUG

Dexamethasone

local peritonsillar infiltration dexamethasone (0.2 mg/kg))

Intervention Type: DRUG

ketamine-dexamethasone

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• children age 3-12 years ASAI,II

Exclusion Criteria

• 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, -

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qazvin University Of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

marzieh beigom khezri

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Qazvin university of medical science

Qazvin, Qazvin Province, Iran

Site Status: RECRUITING

Countries

Iran

Central Contacts

Marzieh Beigom khezri, assistant professor

Role: CONTACT

mkhezri@qums.ac.ir

+98 9123811009

Facility Contacts

Marzieh Beigomb Khezri, assistant professor

Role: primary

mkhezri@qums.ac.ir

+98 9123811009

Other Identifiers

ACTRN12610000658011

Identifier Type: -

Identifier Source: org_study_id