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Efficacy of local anaesthesia of bupivacaine in combination with tramadol in post adenotonsillectomy pain

Preemptive peritonsillar infiltration with bupivacaine in combination with tramadol improves pediatric posttonsillectomy pain better than using bupivacaine or tramadol alone: A randomized, placebo-controlled, double blind clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201308035362N8
Enrollment
120
Registered
2013-08-18
Start date
2010-12-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Local anaesthetics. Condition 2: Acute pain. Local anaesthetics Acute pain

Interventions

Intervention 1: Received peritonsillar injection of bupivacaine 0.5% (1mg/kg) in adrenalin 1:200000 in a volume of 3 cc with normal saline (N/S) before surgical insicion. Intervention 2: Received peri
Prevention
Received peritonsillar injection of bupivacaine 0.5% (1mg/kg) in adrenalin 1:200000 in a volume of 3 cc with normal saline (N/S) before surgical insicion
Received peritonsillar infiltration of tramadol 2mg/kg in adrenalin 1:200000 in a volume of 3 cc with normal saline (N/S) before surgical insicion
Received peritonsillar infiltration of tramadol 2 mg/kg and bupivacaine 1mg/kg in adrenalin 1:200000 in a volume of 3 cc before surgical insicion
Received peritonsillar infiltration of N/S in a volume of 3 cc before surgical insicion

Sponsors

Isfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 15 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 5 to 15 years old who were candidate for tonsillectomy with or without adenoidectomy; exclusion criteria: patients with acute pharyngeal infection; allergy to bupivacaine or tramadol; acute and active infection of respiratory tract with fever and rhonchi; constant use of sedative or analgesic hypnotic; peritonsillar abscess; renal disease; liver disease; asthma and coagulation disorders.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain. Timepoint: Time of 0,15,30,60 minutes in recovery and 4,8,16,28 hour in ward. Method of measurement: ops (objective pain scale).

Secondary

MeasureTime frame
Consciousness level. Timepoint: Time of 0,15,30,60 minutes in recovery and 4,8,16,24 hours in ward. Method of measurement: Watching in 4 grading.;Mean blood pressure - mean heart rate. Timepoint: Time of 0,10,30,60 minutes in operation and 0,30,60 minutes in recovery. Method of measurement: Monitoring.;Nausea and vomiting. Timepoint: After operation to 24 hours. Method of measurement: Watching.;Mean time to awaking. Timepoint: after operation. Method of measurement: Watching.;Mean first time to asking analgesic. Timepoint: After operation to 24 hours. Method of measurement: Watching.;Mean time to extubation. Timepoint: after operation. Method of measurement: Watching.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mohammadreza Safavi

Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences

safavi@med.mui.ac.ir+98 31 1625 5555

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026