Pre-emptive intravenous ketorolac analgesia does not alter the risk of bleeding after tonsillectomy in children

the preoperative use of intravenous ketorolac analgesia does not alter the risk of bleeding after tonsillectomy in children.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001203741

Enrollment

147

Registered

2013-11-04

Start date

2011-12-10

Completion date

2013-05-18

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Background Non-steroidal anti-inflammatory drugs (NSAIDs) inhibit platelet aggregation and prolong bleeding time, which may increase the risk of postoperative bleeding. We investigated the effects of ketorolac (a NSAID) on intra- and postoperative hemorrhage with pediatric tonsillectomy. Methods One hundred forty seven children, aged 2-7 years scheduled for tonsillectomy with or without adenoidectomy were randomized to receive a slow IV infusion over 15 min of either Ketorolac 1mg kg -1 (Group K, n=74) or Paracetamol 15 mg kg-1(Group P, n=73) after induction of anesthesia. Perioperative non-invasive hemoglobin (SpHb) was assessed preoperatively and several times after surgery. Bleeding times were measured before and after surgery. Intraoperative blood loss was estimated. Intensity of postoperative pain was measured using an objective pain scores (OPS). Incidence and severity of post-tonsillectomy bleeding (PTB) were recorded till the 7thpostoperative day.

Interventions

children scheduled for tonsillectomy with or without adenoidectomy were randomized to receive a slow IV infusion over 15 min of either Ketorolac 1mg kg -1, after induction of anesthesia.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

2 Years to 7 Years

Healthy volunteers

Inclusion criteria

ASA physical status I children scheduled for tonsillectomy with or without adenoidectomy. All patients enrolled in this study had normal blood counts, with normal coagulation profile (prothrombin time, activated partial thromboplastin time, platelet count, and bleeding time.

Exclusion criteria

Exclusion criteria included the use of paracetamol or NSAIDs within 6 h or any other analgesic medication within 12 h before surgery, and a known allergy to any of the study drugs.

Outcome results