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Comparing the effects of promethazine and gabapentin as premedication in reducing pain in tonsillectomy operation

A clinical trial on the effects of promethazine and gabapentin as pre-medication in reducing postoperative pain in 7- to 9-year-old patients undergoing tonsillectomy

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017051517756N14
Enrollment
104
Registered
2017-07-05
Start date
2017-07-23
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

Post-operative pain. Pain in throat

Interventions

Intervention 1: Intervention Group 1 (Gabapentin group): The gabapentin group receives 20 milligrams per kilogram along with 50 cc of water one hour before anesthesia. Postoperative pain at 3, 6, 12 a
Treatment - Drugs
Intervention Group 1 (Gabapentin group): The gabapentin group receives 20 milligrams per kilogram along with 50 cc of water one hour before anesthesia. Postoperative pain at 3, 6, 12 and 24 hours afte
Intervention Group 2 (The promethazine group): The group receives 0.5 cc per kilogram and up to a maximum dose of 25 milligram promethazine syrup orally one hour before anesthesia. Postoperative pain

Sponsors

Vice-chancellery for Research, Birjand University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 15 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: non-addiction to and non-use of psychotropic and psychoactive drugs; no history of anxiety, neuropsychiatric, and hyperactivity disorders or chronic pain; age between 7 and 15 years; patient referred by the ENT specialist, co-researcher in this project; non-use of drugs effective on heart rate and pressure; informed consent. Exclusion criteria: Surgery length over 30 minutes; complications during or after surgery, e.g., bleeding and hypoxia

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain severity. Timepoint: 3, 6, 12 and 24 hours after operation. Method of measurement: Medical Objective Pain Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasoud Madihi

Birjand University of Medical Sciences

masoud.madihi@gmail.com+98 56 3239 5680

Outcome results

None listed

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