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The effect of intravenous ketamine plus paracetamol versus intravenous paracetamol alone on postoperative pain, nausea and vomiting after pediatric adenotonsilectomy

The effect of intravenous ketamine plus paracetamol versus intravenous paracetamol alone on postoperative pain, nausea and vomiting after pediatric adenotonsilectomy: a triple blinded randomized clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201402179014N25
Enrollment
98
Registered
2014-05-26
Start date
2014-06-22
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: Pain in throat. Condition 2: Nausea and vomiting. Pain in throat Nausea and vomiting

Interventions

Intervention 1: Intravenous ketamine 0.25 mg/kg (2 ml) single dose plus intravenous acetaminophen 15 mg/kg single dose, 15 min before the end of surgery and every 6 hours until 24 hours after surgery.
Treatment - Drugs
Placebo
Intravenous ketamine 0.25 mg/kg (2 ml) single dose plus intravenous acetaminophen 15 mg/kg single dose, 15 min before the end of surgery and every 6 hours until 24 hours after surgery.
Intravenous normal saline 2 ml single dose plus intravenous acetaminophen 15 mg/kg single dose, 15 min before the end of surgery and every 6 hours until 24 hours after surgery.

Sponsors

Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: (a) 3 to 12 years old; (b) candidate for elective adenotonsilectomy; having one or two criteria based on Physical Status Classification American Society of Anesthesiologists (ASA) Exclusion criteria: (a) history of psychiatric disease; (b) using analgesic within 24 hours before surgery; (c) sensitivity to ketamine or acetaminophen; (d) using cautery for hemostasis.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain severity. Timepoint: at 0.5, 6, 12, and 12 hours after surgery. Method of measurement: based on the CHEOPS Pain Score.;Number of nausea and vomiting. Timepoint: at 0.5, 6, 12, and 12 hours after surgery. Method of measurement: based on clinical observation.

Secondary

MeasureTime frame
The duration of time to use the first narcotic. Timepoint: per min after surgery. Method of measurement: based on medical record.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Lida Noori

Beasat Hospital

Dr.lidanori@yahoo.com+98 918 341 6392

Outcome results

None listed

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